MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB GVF INS 2.5 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158122010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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
Intraoperatively it had not been possible to fix the inlay.The inlay's lower bar broke off.Another inlay was available and was inserted and fixed without any issues.No surgery prolongation, no part remaining in patient, no adverse consequences for patient or user.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Investigation summary 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.

• Brand Name: SIGMA STAB GVF INS 2.5 10MM
• 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: 7291860
• Report Number: 1818910-2018-53979
• Device Sequence Number: 16410885
• Product Code: JWH
• UDI-Device Identifier: 10603295064091
• UDI-Public: 10603295064091
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2018

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: 158122010
• Device Lot Number: D17023421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 02/28/2018; 09/22/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 03/06/2018; 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1