MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PFC SIG RPF INS SZ 3 10MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Model Number	95-1030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Injury (2348); No Code Available (3191)
Date of Event	09/11/2020
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
Revision total knee replacement: bone loss and loosening femoral and tibial components.Not thought to be infected as pathological blood markers normal pre-op.Unconfirmed and unproven suggestion the bone loss and loosening may be associated with a vascular necrosis however unconfirmed at this time.
Event or Problem Description
Additional information received indicated that the interface that appeared to have failed was the cement to bone interface.Depuy cement was not used in the procedure.
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 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.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.Device history lot no deviations or non-conformances were noted.

• Brand Name: PFC SIG RPF INS SZ 3 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: 10606282
• Report Number: 1818910-2020-21193
• Device Sequence Number: 2793313
• Product Code: NJL
• UDI-Device Identifier: 10603295230373
• UDI-Public: 10603295230373
• 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: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 95-1030
• Device Catalogue Number: 951030
• Device Lot Number: 498927
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/05/2020; 12/07/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/26/2020; 12/07/2020
• 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: MBT CEM KEEL TIB TRAY SZ3; MBT CEM KEEL TIB TRAY SZ3; PFC SIG RPF INS SZ 3 10MM; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG PS150 FEM COMP SZ 3 L; SIG PS150 FEM COMP SZ 3 L; MBT CEM KEEL TIB TRAY SZ3; PFC SIG RPF INS SZ 3 10MM; SIG PS150 FEM COMP SZ 3 L
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR