MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB GVF INS 3 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158123008
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
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
Today (b)(6) doctor performed a left knee replacement.Doctor could not get the insert to click into the tibial tray on the lateral side.
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.Product complaint #: (b)(4).Investigation summary: the device was reviewed by the manufacturer and the failure mode could not be confirmed.Root cause undetermined.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.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 STAB GVF INS 3 8MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8716595
• Report Number: 1818910-2019-96360
• Device Sequence Number: 1844485
• Product Code: JWH
• UDI-Device Identifier: 10603295064244
• UDI-Public: 10603295064244
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

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: 158123008
• Device Lot Number: D19042179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1