MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 7 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number	101214070
Medical Device Problem Codes	Material Discolored (1170); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)
Date of Event	11/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 received.Litigation alleges severe pain, which affects his ability to walk and sit.Radiograph showed osteolysis and showed a large fluid collection with debris consistent with a granulomatous pseudotumor secondary to metal reaction.It was also reported that there was mild amount of fluid and some brownish staining of the synovial tissues throughout, but no significant pseudotumor.Doi: (b)(6) 2008: dor: (b)(6) 2016; (right hip).This complaint is linked to (b)(4); (left hip).Update 4 jun 2018 pinnacle ppf received.In addition to what were previous alleged, ppf alleges elevated metal ions.However, it was previously confirmed that the blood levels for metal ions were below 7(no unit provided).Shall there be new information.
Additional Manufacturer Narrative
Pc(b)(4).No device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRI-LOCK BPS SZ 7 HI OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7660155
• Report Number: 1818910-2018-63730
• Device Sequence Number: 2527329
• Product Code: MRA
• UDI-Device Identifier: 10603295001096
• UDI-Public: 10603295001096
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2018

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 Catalogue Number: 101214070
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 07/03/2018; 08/10/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 07/11/2018; 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 154