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

Model Number	96-0015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	09/02/2021
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
Subject id: (b)(6).Study: dots.Clinical adverse event received for failed tka due to polywear, osteolysis, tibial loosening.Event is serious and is considered moderate.Event is related to device and not related to procedure.Date of implant: (b)(6) 2002, date of event: (b)(6) 2021, date of revision: (b)(6) 2021 (right knee).Treatment: revision of all components.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available x-rays and photographs were reviewed and according with the visual inspection of the pictures the complaint cannot be confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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 FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12539534
• Report Number: 1818910-2021-21219
• Device Sequence Number: 19859299
• Product Code: JWH
• UDI-Device Identifier: 10603295232049
• UDI-Public: 10603295232049
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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: 96-0015
• Device Catalogue Number: 960015
• Device Lot Number: 313812
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/29/2021
• 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: CEMENT MFG AND PRODUCT NAME UNKNOWN; PFC SIGMA CRVD INSERT SZ5 8MM; PFC SIGMA MOD TIB TRAY CEM SZ5; PFC*SIGMA C/R NPOR FEM RT SZ 5; PFC*SIGMA/OV/DOME PAT 3PEG,41; CEMENT MFG AND PRODUCT NAME UNKNOWN; PFC SIGMA CRVD INSERT SZ5 8MM; PFC SIGMA MOD TIB TRAY CEM SZ5; PFC*SIGMA C/R NPOR FEM RT SZ 5; PFC*SIGMA/OV/DOME PAT 3PEG,41
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 100