MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PFC SIG RPF INS SZ 4 12.5MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Model Number	95-1041
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
The patient was revised to address increasing femoral pain.Femoral and patella revision performed.Oxidation and wear was noted on both the patella and polyethylene insert.Femur came off very easily, possibly was loose at the implant/cement interface.Unknown bone cement was used.Product codes & lot numbers were unavailable for components other than the insert.No surgical delay reported.Original implant date was sometime in 2005.Doi: 2005; dor: (b)(6) 2021; right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : no lot information available.

• Brand Name: PFC SIG RPF INS SZ 4 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
• MDR Report Key: 12204625
• Report Number: 1818910-2021-15646
• Device Sequence Number: 19943679
• Product Code: NJL
• UDI-Device Identifier: 10603295230427
• UDI-Public: 10603295230427
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 95-1041
• Device Catalogue Number: 951041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/17/2021
• 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: BONE CEMENT (UNK MANUFACTURER & PRODUCT INFO); OVAL PATELLA; PFC SIG RPF INS SZ 4 12.5MM; SIZE 4 RIGHT SIGMA RPF FEMUR; BONE CEMENT (UNK MANUFACTURER & PRODUCT INFO); OVAL PATELLA; PFC SIG RPF INS SZ 4 12.5MM; SIZE 4 RIGHT SIGMA RPF FEMUR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 68