MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PFC SIG RPF INS SZ 4 10MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Model Number	95-1040
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/27/2020
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
It was reported that there was a wear in the polyethylene.Doi: (b)(6) 2009; dor: (b)(6) 2020; left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.H10 additional narrative:  added: d4 (lot) corrected: g1.

• Brand Name: PFC SIG RPF INS SZ 4 10MM
• 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: 10673593
• Report Number: 1818910-2020-22231
• Device Sequence Number: 19458868
• Product Code: NJL
• UDI-Device Identifier: 10603295230410
• UDI-Public: 10603295230410
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• 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): 09/27/2020

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: 95-1040
• Device Catalogue Number: 951040
• Device Lot Number: D5PDE4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/24/2020
• 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: PFC SIGMA/OV/DOME PAT 3PEG,38
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 92