MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA DIS AUG 8MM,SZ5,RGHT; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Catalog Number	960903
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.(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
On (b)(6) 2017 the patient undergoes a revision right total knee replacement to a hinged knee replacement construct due to failure of right total knee replacement secondary to instability and posterolateral corner deficiency.Femoral component and insert were revised and depuy femoral implant, augments, and tibial insert were implanted.Doi: (b)(6) 2017; dor: (b)(6) 2017; 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.H10 additional narrative: corrected: h6.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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9402084
• Report Number: 1818910-2019-119595
• Device Sequence Number: 19361624
• Product Code: JWH
• UDI-Device Identifier: 10603295234494
• UDI-Public: 10603295234494
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K082500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 960903
• Device Lot Number: 710440
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/03/2020
• 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: COMPETITOR BONE CEMENT; MBT REV TIB TRAY SIZE 4 15MM; MBT TRAY SLEEVE POR M/L 37MM; PFCSIGMA 3POST RDDOME PAT 41MM; UNIVERSAL STEM 75X18MM FLUTED; COMPETITOR BONE CEMENT; MBT REV TIB TRAY SIZE 4 15MM; MBT TRAY SLEEVE POR M/L 37MM; PFCSIGMA 3POST RDDOME PAT 41MM; UNIVERSAL STEM 75X18MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR