MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/S NPOR FEM LT SZ 4; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0044
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	07/07/2020
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
Subject id: (b)(6).Study: dots.Clinical notification received for revision of left total knee to address aseptic loosening date of implantation: (b)(6) 2002.Date of revision: (b)(6) 2020.(left knee).Treatment: femur, tibial tray, and tibial insert were revised; patella retained.Update: medical records received ad 21 oct 2020 were reviewed on 27 oct 2020 by a clinician to identify patient harms/product issues.Primary operative notes (b)(6) 2002 indicate the patient received a left total knee replacement due to end stage osteoarthritis.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2020 indicates the patient received an additional left total knee revision due to significant polyethylene wear and varus collapse of the knee, pain and decreased function.The insert was removed and indicated to have significant wear.The tibial and femoral components were noted to be well fixed but also revised.Surgery was completed without indication of complication by the surgeon.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this report was not received for examination.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.

• 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: 10817197
• Report Number: 1818910-2020-24338
• Device Sequence Number: 14474943
• Product Code: JWH
• UDI-Device Identifier: 10603295232247
• UDI-Public: 10603295232247
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K950010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2020
• 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): 10/27/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-0044
• Device Catalogue Number: 960044
• Device Lot Number: 312280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/05/2020
• 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: PFC SIGMA STAB INS SZ3 10MM; PFC SIGMA TIB TRAY CEM SZ3; PFC*SIGMA/OV/DOME PAT 3PEG,38; PFC SIGMA STAB INS SZ3 10MM; PFC SIGMA TIB TRAY CEM SZ3; PFC*SIGMA/OV/DOME PAT 3PEG,38
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 175