MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA CRVD GVF INS 2 12.5MM; KNEE TIBIAL BEARING/INSERT

Catalog Number	158111012
Medical Device Problem Codes	Fracture (1260); Misconnection (1399)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	09/22/2017
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
It was reported that the insert had a broken locking mechanism.
Additional Manufacturer Narrative
Product complaint # : (b)(4).The reported event has been evaluated and will be monitored.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 will be filed as appropriate.
Event or Problem Description
Complaint description: it was reported that the insert had a broken locking mechanism.

• Brand Name: SIGMA CRVD GVF INS 2 12.5MM
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; suzhou industrial park; warsaw IN 46581 0988
• MDR Report Key: 7002130
• Report Number: 1818910-2017-27846
• Device Sequence Number: 1184525
• Product Code: JWH
• UDI-Device Identifier: 10603295063100
• UDI-Public: 10603295063100
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 158111012
• Device Lot Number: D16042399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 11/04/2017
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1