MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/S NPOR FEM LT SZ 5; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0045
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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
Tibial and femoral aseptic loosening at the implant\cement interface.Cement not from depuy.Device removed and patient experienced pain.Dor: (b)(6) 2021.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12480698
• Report Number: 1818910-2021-20231
• Device Sequence Number: 14405910
• Product Code: JWH
• UDI-Device Identifier: 10603295232254
• UDI-Public: 10603295232254
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K971189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 08/26/2021

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: 96-0045
• Device Catalogue Number: 960045
• Device Lot Number: 1161704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/16/2021
• 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: COMPETITOR CEMENT; PFC SIGMA MOD TIB TRAY CEM SZ5; PFC SIGMA STAB INS SZ5 10MM; PFC*SIGMA C/S NPOR FEM LT SZ 5
• Outcome Attributed to Adverse Event: Required Intervention