PINNACLE MTL INS NEUT36IDX56OD

METAL LINER

This device is manufactured by DEPUY INTERNATIONAL, DEPUY ORTHOPAEDICS US.

The following problems were reported about this device:

Year	Description	Events/year	Type
2024	Unspecified Tissue Injury	1	Patient
2024	Pain	2	Patient
2024	Hypersensitivity/Allergic reaction	1	Patient
2024	Adverse Event Without Identified Device or Use Problem	1	Device
2023	Pain	1	Patient
2023	Insufficient Information	2	Patient
2023	Foreign Body Reaction	2	Patient
2023	Naturally Worn	3	Device
2023	Adverse Event Without Identified Device or Use Problem	1	Device
2022	Adverse Event Without Identified Device or Use Problem	1	Device
2021	Unspecified Tissue Injury	1	Patient
2021	Swelling/ Edema	1	Patient
2021	Muscle/Tendon Damage	1	Patient
2021	Foreign Body Reaction	1	Patient
2021	Naturally Worn	1	Device
2019	Naturally Worn	5	Device
2019	Insufficient Information	1	Device
2019	Difficult to Remove	1	Device
2019	Device Dislodged or Dislocated	4	Device
2019	Biocompatibility	2	Device
2019	Adverse Event Without Identified Device or Use Problem	12	Device
2018	Noise, Audible	1	Device
2018	Naturally Worn	9	Device
2018	Material Disintegration	4	Device
2018	Insufficient Information	8	Device
2018	Device Dislodged or Dislocated	2	Device
2018	Biocompatibility	3	Device
2018	Appropriate Term/Code Not Available	5	Device
2018	Adverse Event Without Identified Device or Use Problem	20	Device
2017	Noise, Audible	6	Device
2017	Naturally Worn	24	Device
2017	Metal Shedding Debris	6	Device
2017	Material Disintegration	8	Device
2017	Insufficient Information	39	Device
2017	Device Dislodged or Dislocated	6	Device
2017	Corroded	2	Device
2017	Biocompatibility	2	Device
2017	Appropriate Term/Code Not Available	22	Device
2017	Adverse Event Without Identified Device or Use Problem	11	Device
2016	Noise, Audible	2	Device
2016	Naturally Worn	11	Device
2016	Metal Shedding Debris	2	Device
2016	Material Disintegration	1	Device
2016	Insufficient Information	13	Device
2016	Device Dislodged or Dislocated	4	Device
2016	Corroded	2	Device
2016	Appropriate Term/Code Not Available	18	Device
2016	Adverse Event Without Identified Device or Use Problem	1	Device
2015	Naturally Worn	21	Device
2015	Material Disintegration	1	Device
2015	Insufficient Information	23	Device
2015	Device Dislodged or Dislocated	1	Device
2015	Corroded	1	Device
2015	Biocompatibility	1	Device
2015	Appropriate Term/Code Not Available	12	Device
2015	Adverse Event Without Identified Device or Use Problem	6	Device
2014	Noise, Audible	10	Device
2014	Naturally Worn	37	Device
2014	Migration or Expulsion of Device	1	Device
2014	Metal Shedding Debris	14	Device
2014	Material Disintegration	6	Device
2014	Loose or Intermittent Connection	1	Device
2014	Insufficient Information	54	Device
2014	Device Slipped	1	Device
2014	Device Dislodged or Dislocated	5	Device
2014	Corroded	1	Device
2014	Appropriate Term/Code Not Available	21	Device
2014	Adverse Event Without Identified Device or Use Problem	5	Device
2013	Use of Device Problem	1	Device
2013	Noise, Audible	1	Device
2013	Naturally Worn	8	Device
2013	Metal Shedding Debris	4	Device
2013	Material Disintegration	3	Device
2013	Malposition of Device	1	Device
2013	Insufficient Information	15	Device
2013	Device Dislodged or Dislocated	2	Device
2013	Appropriate Term/Code Not Available	9	Device
2013	Adverse Event Without Identified Device or Use Problem	2	Device
2012	Unspecified Tissue Injury	1	Patient
2012	Synovitis	1	Patient
2012	Swelling/ Edema	2	Patient
2012	Scar Tissue	1	Patient
2012	Necrosis	2	Patient
2012	Metal Related Pathology	1	Patient
2012	Hypersensitivity/Allergic reaction	2	Patient
2012	Foreign Body Reaction	1	Patient
2012	Fatigue	2	Patient
2012	Cyst(s)	2	Patient
2012	Noise, Audible	2	Device
2012	Naturally Worn	9	Device
2012	Metal Shedding Debris	3	Device
2012	Material Disintegration	2	Device
2012	Insufficient Information	9	Device
2012	Device Dislodged or Dislocated	2	Device
2012	Appropriate Term/Code Not Available	3	Device
2012	Application Network Problem	1	Device
2012	Adverse Event Without Identified Device or Use Problem	2	Device
2011	Noise, Audible	1	Device
2011	Naturally Worn	4	Device
2011	Material Disintegration	2	Device
2011	Insufficient Information	4	Device
2011	Device Dislodged or Dislocated	1	Device
2010	Naturally Worn	2	Device
2010	Metal Shedding Debris	1	Device
2010	Malposition of Device	1	Device
2009	Insufficient Information	1	Device
2008	Noise, Audible	1	Device
2008	Naturally Worn	3	Device
2008	Metal Shedding Debris	1	Device
2008	Insufficient Information	1	Device
2008	Device Dislodged or Dislocated	2	Device
2008	Appropriate Term/Code Not Available	3	Device
2008	Adverse Event Without Identified Device or Use Problem	1	Device
2007	Noise, Audible	1	Device
2007	Naturally Worn	2	Device
2007	Insufficient Information	3	Device
2007	Device Dislodged or Dislocated	1	Device
2007	Appropriate Term/Code Not Available	1	Device
2006	Naturally Worn	2	Device
2006	Insufficient Information	3	Device
2006	Device Dislodged or Dislocated	1	Device
2006	Appropriate Term/Code Not Available	2	Device
2006	Adverse Event Without Identified Device or Use Problem	1	Device
2005	Insufficient Information	2	Device
2005	Adverse Event Without Identified Device or Use Problem	1	Device
2004	Insufficient Information	2	Device
2004	Device Dislodged or Dislocated	1	Device