MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA STAB+ INS 22.5MM SZ3; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	962735
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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 the patient's sigma knee was revised due to pain.Her original primary tibial tray component was previously revised on (b)(6) 2009 for aseptic loosening.During this revision procedure, her primary fixed bearing posterior stabilized femoral component and her stabilized plus revision insert were revised and replaced by a tc3 femoral component and a fixed bearing tc3 insert, since the patient had a fair amount of collateral ligamentation laxity.Preoperatively, surgeon thought that the patient's revision tibial tray and fluted stem may have been loose; however, intraoperative testing proved that they were not loose.Surgeon therefore decided to revise only the femoral component, thinking it might be loose and also to enable him to utilize a more constrained liner to address the laxity.It appeared that the primary femoral component may not have been loose, but it did come off fairly easily.Doi: (b)(6) 2005; (b)(6) 2009 (insert).Dor: (b)(6) 2019 left knee.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).No device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.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 22.5MM SZ3
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9211034
• Report Number: 1818910-2019-110807
• Device Sequence Number: 11500748
• Product Code: JWH
• UDI-Device Identifier: 10603295244127
• UDI-Public: 10603295244127
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K963117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: 962735
• Device Lot Number: 485735A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK ATTUNE KNEE TIBIAL TRAY; UNKNOWN KNEE TIBIAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR