MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 6 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number	1012-14-060
Medical Device Problem Codes	Corroded (1131); Degraded (1153)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Test Result (2695); No Code Available (3191); Metal Related Pathology (4530)
Date of Event	07/27/2020
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
Unf and medical records received.Pinnacle claim submission form alleges elevated metal ions and metallosis/metal wear.After review of medical records patient was revised to address failed right total hip replacement.Revision notes reported that we clearly noted that the soft tissue lining the hip might have slightly darkened from metal wear, but that significantly was far from black.We did have corrosion at the trunnion.We were able to explant the size 40 diameter femoral head, immediately noted the trunnion had mild corrosion.Doi: (b)(6) 2008.Dor: (b)(6) 2020; (right hip).
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: TRI-LOCK BPS SZ 6 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10818708
• Report Number: 1818910-2020-24368
• Device Sequence Number: 11793170
• Product Code: KWA
• UDI-Device Identifier: 10603295001089
• UDI-Public: 10603295001089
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• 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,Followup
• Report Date (Section B): 10/28/2020

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: 1012-14-060
• Device Catalogue Number: 101214060
• Device Lot Number: C5HAH1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 11/13/2020; 09/26/2023
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 11/16/2020; 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12/14 ARTICUL 40MM M SPEC+1.5; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX40MM; PINNACLE MTL INS NEUT40IDX60OD; PINNACLE SECTOR II CUP 60MM; TRI-LOCK BPS SZ 6 HI OFFSET; 12/14 ARTICUL 40MM M SPEC+1.5; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX40MM; PINNACLE MTL INS NEUT40IDX60OD; PINNACLE SECTOR II CUP 60MM; TRI-LOCK BPS SZ 6 HI OFFSET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male