MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.¿ 300635604 SIGMA STAB GVF INS 3 8MM; KNEE TIBIAL BEARING/INSERT

Catalog Number	158123008
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
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 during the surgery the insert was not connected into a tibial tray.
Additional Manufacturer Narrative
It was reported that during the surgery the insert was not connected into a tibial tray.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 will be filed as appropriate.
Additional Manufacturer Narrative
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 3 8MM
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.¿ 300635604; no.299 changyang st; suzhou industrial park; suzhou 21512 -6; CH 21512-6
• MDR Report Key: 6732301
• Report Number: 1818910-2017-21509
• Device Sequence Number: 19175312
• Product Code: JWH
• UDI-Device Identifier: 10603295064244
• UDI-Public: 10603295064244
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2017

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: 158123008
• Device Lot Number: D15122562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 07/14/2017; 10/07/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 08/11/2017; 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR