MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PFC SIGMA STAB+ INS 10MM SZ2; TIBIAL INSERT

Catalog Number	962710
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2017
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
Patient initiated complaint; medical records received.After review of the medical records for mdr reportability, the patient was revised for tibial malpositioning, poly wear, metallosis, and femoral loosening at an unknown interface/cement.
Additional Manufacturer Narrative
(b)(4).Investigation summary: review of the provided explant photograph confirms the reported event.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.Device history lot: product code 962710, lot number ed6l74.Device history batch: null.Device history review : dhr reviewed - no nonconformances were noted.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC SIGMA STAB+ INS 10MM SZ2
• Common Device Name: TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7071666
• Report Number: 1818910-2017-50461
• Device Sequence Number: 945113
• Product Code: JWH
• UDI-Device Identifier: 10603295243885
• UDI-Public: 10603295243885
• Combination Product (Y/N): N
• Initial Reporter State: MA
• PMA/510(K) Number: K950010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2017

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: 962710
• Device Lot Number: ED6L74
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 03/12/2018
• 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: 57 YR