MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC*SIGMA TC3 FEM RT SZ2.5; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0092
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/12/2019
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
It was reported that the surgeon converted tc3 to lps distal femur due to mcl deficiency after a fall.Femur and femoral adapter and bolt were put in 2015; insert was placed in 2018.Doi: 2015 (femur and femoral adapter and bolt) and 2018 (insert); dor: (b)(6) 2019; 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.Corrected:h6.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 REVISION IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 9548509
• Report Number: 1818910-2020-00509
• Device Sequence Number: 16729567
• Product Code: JWH
• UDI-Device Identifier: 10603295232599
• UDI-Public: 10603295232599
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/12/2019

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 Model Number: 96-0092
• Device Catalogue Number: 960092
• Device Lot Number: D33FP4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 02/04/2020
• 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: 47 YR
• Patient Weight: 120