MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ3 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-02-090
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Synovitis (2094); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Pinnacle litigation records received.Prior to revision patient alleges pain, stiffness, injury, instability, weakness, metallosis and elevated cobalt and chromium level.During revision doctor found out corrosion at the trunnion and head bore, pseudotumor, inflamed hypertrophic synovium and anterior capsule was thickened with an armd reaction and this was debrided.Doi: (b)(6) 2008; dor: (b)(6) 2020 left hip.

• Brand Name: SUMMIT DUOFIX TAP SZ3 STD OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11517587
• Report Number: 1818910-2021-05501
• Device Sequence Number: 11749076
• Product Code: LPH
• UDI-Device Identifier: 10603295059448
• UDI-Public: 10603295059448
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1570-02-090
• Device Catalogue Number: 157002090
• Device Lot Number: B58DG1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICULEZE M HEAD 36MM +1.5; PINNACLE 100 ACET CUP 50MM; PINNACLE MTL INS NEUT36IDX50OD; SUMMIT DUOFIX TAP SZ3 STD OFF
• Outcome Attributed to Adverse Event: Required Intervention