MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM LT SZ 2; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/27/2019
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
Clinical notification received for left knee revision to address instability.Date of implantation: (b)(6) 2015; date of revision: (b)(6) 2019; (left knee).
Event or Problem Description
Update 27 jan 2020.Medical records were reviewed to identify patient harms/product issues.The patient underwent a left knee revision due to instability and synovitis.The surgeon noted minimal tibial insert wear.The tibial insert was the only component revised.The tibial tray, femoral component, and patellar component were well-fixed and retained.Doi: (b)(6) 2015.Dor: (b)(6) 2019 left knee.
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• 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: 9637407
• Report Number: 1818910-2020-03207
• Device Sequence Number: 16872078
• Product Code: JWH
• UDI-Device Identifier: 10603295231943
• UDI-Public: 10603295231943
• 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: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

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: 96-0002
• Device Catalogue Number: 960002
• Device Lot Number: 8035464
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 61