MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD GVF INS 4 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-14-012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/16/2021
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
Dair procedure for infection left pfc sigma total knee replacement primary surgery uncertain however believed to be royal newcastle centre primary surgeon dr michael tarrant.Primary surgery date (b)(6) 2009 or (b)(6) 2009.Doi: (b)(6) 2009.Dor: (b)(6) 2021.Left knee.
Additional Manufacturer Narrative
Product complaint # (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.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.
Event or Problem Description
A.) was there any suggestion by anyone indicating that there was or may be deficiency with the product(s)? if yes please provide details.B.) can you please clarify, were the femoral component and tibial tray removed? it was a diar procedure which would indicate only the bearing would be changed allowing a thorough washout of the joint space.As explained i did not attend and i do not recall there was any suggestion that the components were at fault.From the best of my knowledge this was a diar procedure for infection.

• Brand Name: SIGMA CRVD GVF INS 4 12.5MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12563041
• Report Number: 1818910-2021-21738
• Device Sequence Number: 16445467
• Product Code: JWH
• UDI-Device Identifier: 10603295063469
• UDI-Public: 10603295063469
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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,Followup
• Report Date (Section B): 09/17/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1581-14-012
• Device Catalogue Number: 158114012
• Device Lot Number: DC8HW4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 10/24/2021
• 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: PFC KEEL TIB TRAY CEM SZ4; SIG C/R POROCOAT FEM LT SZ 5; SIGMA CRVD GVF INS 4 12.5MM; PFC KEEL TIB TRAY CEM SZ4; SIG C/R POROCOAT FEM LT SZ 5; SIGMA CRVD GVF INS 4 12.5MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR