MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA/RD/DOME PAT 3PEG,35; SIGMA KNEE PRIMARY : KNEE PATELLA

Model Number	96-0111
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/01/2021
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
Patient had a loose femur and experienced instability.Dr.Replaced it with a tc3 femoral revision with a press fit stem and sleeve.Surgery delay of 75 minutes.Procedure successfully completed.Patient's poly and patella were worn and oxidized.It was replaced with an aox poly ence.
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.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11968685
• Report Number: 1818910-2021-12256
• Device Sequence Number: 3674101
• Product Code: NJL
• UDI-Device Identifier: 10603295232667
• UDI-Public: 10603295232667
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/25/2021

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: 96-0111
• Device Catalogue Number: 960111
• Device Lot Number: 3246269
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/15/2021
• 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 SIGMARP STB TB IN 4 10.0; SIG PS CEM FEM W/LUGS RT SZ4
• Outcome Attributed to Adverse Event: Required Intervention