MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SIGMA PLI GVF INS 4 8MM; TIBIAL INSERT

Catalog Number	158104008
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2017
Type of Reportable Event	Serious Injury
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
The following implants were removed by surgeon during revision surgery due to polyethylene wear and tibial and femoral loosening size 4 tibia.866024, lot 2063687; size 4 left cr femur 960004, lot unreadable; size 4 8mm pli insert 158104008?, lot 2048223 original surgery approximately 11 years ago.No report is necessary.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA PLI GVF INS 4 8MM
• Common Device Name: TIBIAL INSERT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds IN LS11 8DT; UK LS11 8DT
• MDR Report Key: 7124975
• Report Number: 1818910-2017-51866
• Device Sequence Number: 1210680
• Product Code: JWH
• UDI-Device Identifier: 10603295062608
• UDI-Public: 10603295062608
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 158104008
• Device Lot Number: 2048223
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 08/23/2018
• 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