MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIG RPF INS SZ 4 10MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Catalog Number	951040
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.
Event or Problem Description
Revision of a pfc sigma.Reason for revision was due to poly wear.Femoral, tibial, and patella implants were not revises as they were well fixed.Poly debris was removed and the area was thoroughly cleaned.No indication of wear on the femoral or tibial components.Patient left side.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: revision of a pfc sigma from [year].Reason for revision was due to poly wear.Femoral, tibial, and patella implants were not revises as they were well fixed.Poly debris was removed and the area was thoroughly cleaned.No indication of wear on the femoral or tibial components.Patient left side.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment(b)(4).The photo investigation found wear, and damage consistent with 19 years of service with articular loading within anticipated regions of the insert.The posterior-medial portion of the insert was damaged, consistent with rotation between the femoral component and the mating articular portions of the tibial insert.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the pfc sig rpf ins sz 4 10mm would have contributed to the complained device issue.Based on the investigation findings and the provided information, a potential cause was not established and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device below and no non-conformances or manufacturing irregularities were identified.Product code: 951040.Lot number: zp8pg4000.1) quantity manufactured: 11.2) date of manufacture: 4/25/2005.3) any anomalies or deviations identified in dhr: none.4) expiry date: 4/24/2010.5) ifu-0902-00-769.

• Brand Name: PFC SIG RPF INS SZ 4 10MM
• Common Device Name: PFC SIGMA RP-F : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 20558651
• Report Number: 1818910-2024-22562
• Device Sequence Number: 8980048
• Product Code: NJL
• UDI-Device Identifier: 10603295230410
• UDI-Public: (01)10603295230410(17)100424(10)ZP8PG4000
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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 Expiration Date: 04/24/2010
• Device Catalogue Number: 951040
• Device Lot Number: ZP8PG4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2005
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female