MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 SIGMA CRVD GVF INS 3 8MM; KNEE TIBIAL BEARING/INSERT

Catalog Number	158113008
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/16/2017
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
Patient was revised to address infection and loosening of the tibial tray.The insert was pitting.
Additional Manufacturer Narrative
Examination of the returned device confirmed the reported damage.Depuy considers the investigation closed.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 CRVD GVF INS 3 8MM
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou 21512 -6; CH 21512-6
• MDR Report Key: 6721984
• Report Number: 1818910-2017-21306
• Device Sequence Number: 188519
• Product Code: JWH
• UDI-Device Identifier: 10603295063322
• UDI-Public: 10603295063322
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 158113008
• Device Lot Number: D11010193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 01/02/2018
• 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: 67 YR