MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 3 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number	1012-14-030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Synovitis (2094)
Date of Event	07/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
On (b)(6) 2016: patient underwent a revision after experiencing grinding/squeaking and dislocation with suspected inlay disassociation.Patient was noted to be pain and symptom free.X-ray showed decentralized femoral head.Revision operative note indicated synovitis, trochanteric bursitis, and metallosis.Dislocation and disassociation were confirmed.There were signs of implant impingement, but it was noted to be secondary to the grinding after the disassociation.The femoral head and acetabular liner were revised.Right side affected.Doi: (b)(6) 2015, dor: (b)(6) 2016 - revision of inlay.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.The device manufacturing record (mre) has been reviewed.There were no related deviations, anomalies or non-conformances identified.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.Device history lot: the device manufacturing record (mre) has been reviewed.There were no related deviations, anomalies or non-conformances identified.Device history review: the device manufacturing record (mre) has been reviewed.There were no related deviations, anomalies or non-conformances identified.

• Brand Name: TRI-LOCK BPS SZ 3 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: 11664943
• Report Number: 1818910-2021-07906
• Device Sequence Number: 16889096
• Product Code: KWA
• UDI-Device Identifier: 10603295001058
• UDI-Public: 10603295001058
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: 1012-14-030
• Device Catalogue Number: 101214030
• Device Lot Number: 622232
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 04/29/2021
• 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: APEX HOLE ELIM POSITIVE STOP.; ARTICUL/EZE BALL 32 +5 BR.; PINN MAR NEUT 32IDX52OD.; PINNACLE SECTOR II CUP 52MM.; TRI-LOCK BPS SZ 3 HI OFFSET.; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +5 BR; PINN MAR NEUT 32IDX52OD; PINNACLE SECTOR II CUP 52MM; TRI-LOCK BPS SZ 3 HI OFFSET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 90