MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA FEM ADAPTER 7 DEGREE; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Catalog Number	960782
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Sales rep report: a replacement of a right knee joint prosthesis will be perform on monday (b)(6) 2018.This right knee joint prosthesis (product tc3 depuy) was implanted on (b)(6) 2014 and replaced another right knee joint prothesis because the patient had medial femorotibial and patellofemoral pains.Dob : (b)(6).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device(s) confirms the reported event.Product problem has not been identified.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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. .

• Brand Name: SIGMA FEM ADAPTER 7 DEGREE
• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0998
• MDR Report Key: 7424932
• Report Number: 1818910-2018-57240
• Device Sequence Number: 1544137
• Product Code: JWH
• UDI-Device Identifier: 10603295233923
• UDI-Public: 10603295233923
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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 Catalogue Number: 960782
• Device Lot Number: 479567
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 10/15/2018
• 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: 56 YR