MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 9 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number	1012-14-090
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Granuloma (1876); Pain (1994); Visual Impairment (2138); Discomfort (2330); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).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
Pcf and medical records received.After review of medical records, patient undergone physical examination last (b)(6) 2017.Recent labs reveal cobalt increased from 20.2 to 25.Chromium is stable at 11.It was 10 before.The patient has significant functional deficits, recent visual problem, trochanter tenderness, pain in rotation of the leg, leg length discrepancy, and severe right hip stiffness.The patient ambulates with an antalgic trendelenburg gait and moves about at a moderate pace.Medical records also stated an osteolysis in the right acetabulum with metal on metal implant.Patient was revised to address right failed total hip arthroplasty, metal on metal reaction, osteolysis, granuloma, elevated ion counts, and mild taper corrosion.Operative notes stated no evidence of infection.Surgeon performed extensive debridement on granuloma tissue.Doi: (b)(6) 2009.Dor: (b)(6) 2017; right hip.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRI-LOCK BPS SZ 9 HI OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9818750
• Report Number: 1818910-2020-07477
• Device Sequence Number: 11530307
• Product Code: KWA
• UDI-Device Identifier: 10603295001119
• UDI-Public: 10603295001119
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1012-14-090
• Device Catalogue Number: 101214090
• Device Lot Number: CN7DE1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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: 58 YR
• Patient Weight: 76