MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PFC SIG RPF INS SZ 3 12.5MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Model Number	95-1031
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient required revision knee surgery for an unstable tibial insert & worn patella.On opening the joint, the patella showed some wear & yellow discoloration indicative of poly wear.When the joint was distracted medically, there was some gapping.On removal of tibial insert it also showed some wear on the posterior medial side.A new insert & patella implant were inserted.Patient had good rom & was stable at conclusion of surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not received for examination.Based on provided evidence, it was not possible to confirm a worn condition on the device.The overall appearance and color of the device is consistent with implanted period of time, it is not uncommon to see a discoloration or degradation in color due to being exposed to body fluids over the years.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PFC SIG RPF INS SZ 3 12.5MM
• Common Device Name: PFC SIGMA RP-F : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15939623
• Report Number: 1818910-2022-24683
• Device Sequence Number: 15051495
• Product Code: NJL
• UDI-Device Identifier: 10603295230380
• UDI-Public: 10603295230380
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 12/08/2022

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: 95-1031
• Device Catalogue Number: 951031
• Device Lot Number: Y89CJ4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 12/08/2022; 02/13/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 12/13/2022; 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2004
• 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: PFC*SIGMA/OV/DOME PAT 3PEG,38.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 70 KG