MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIG CR NPOR FEM RT SZ 4N; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-01-400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	09/19/2020
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
The patient was revised to address stiffness.The patient underwent a sigma rp cvd construct several years ago.According to the patient, he's never done well with his right knee.His right knee has been fairly stiff since his surgery in 2017.Surgeon elected to remove the femur, insert, and tibia and proceed with a revision construct to relieve some of the stiffness and help the patient regain motion.No surgical delay reported.Doi: (b)(6) 2017.Dor: (b)(6) 2020.Right knee.
Additional Manufacturer Narrative
No device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: PFC SIG CR NPOR FEM RT SZ 4N
• 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: 10609617
• Report Number: 1818910-2020-21273
• Device Sequence Number: 16755420
• Product Code: JWH
• UDI-Device Identifier: 10603295074779
• UDI-Public: 10603295074779
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2020

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: 1960-01-400
• Device Catalogue Number: 196001400
• Device Lot Number: C31871
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/06/2020
• 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; SIG RP AOX CRV INS SZ4 10; MBT CEM KEEL TIB TRAY SZ3; SIG RP AOX CRV INS SZ4 10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 86