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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); No Code Available (3191)
Date of Event	02/14/2018
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
Maude report received.It was reported that the patient had her knees replaced: right ¿unicompartmental¿ knee arthroplasty done in 2002, left total knee arthroplasty done in 2003, and conversion of right unicompartmental to total knee arthroplasty done in 2003.The right knee implant is a depuy sigma knee with a stabilized 15mm tibial insert sz 2.5, (93-0053-500), sigma non-porous right sz 3 femoral (112934, 96-0111), knee patella 35mm round 3 peg onset uhmwpe pfc sigma, 1581-25-000, mod tibial tray cemented.The left knee implant is a depuy sigma tibial poly stab#2 10mm (1024658, 96-0110), knee patella pfc sigma round/dome 3 peg 32mm, 96-0043-500, sigma nonporous femoral left sz 3.All three artificial joints consist of cocr components.She continuously developed an effusion of the right revised tka.Cobalt and chromium synovial fluid from right knee aspiration done 2018, and chromium level was 2.0 mcg/l and cobalt level was not detected.Right knee.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 9962552
• Report Number: 1818910-2020-10785
• Device Sequence Number: 13638699
• Product Code: JWH
• UDI-Device Identifier: 10603295232667
• UDI-Public: 10603295232667
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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: 96-0111
• Device Catalogue Number: 960111
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 05/13/2020
• 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: SIG MOD TIB TRAY CEM COCR 2.5; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE TIBIAL INSERT
• Outcome Attributed to Adverse Event: Required Intervention