MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA FEM ADAPTER NEUTRAL BOLT; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Model Number 96-0783

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Pain (1994); No Code Available (3191)

Event Date 12/09/2019

Event Type  Injury  

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 Description

Patient was revised to address pain and instability.It was reported that this patient had a knee revision last (b)(6) 2019 where his surgeon used a sigma tc3 revision system.According to his surgeon that patient came and seen him sometime ago because she was still experiencing pain and instability in patient left knee.After evaluation surgeon determines that her knee was tight in extension and loose in flexion.Surgeon explants the patients tc3 femur, femoral adaptor , neutral bolt, universal stem, and tc3 insert.He upsized the femur to help tighten the flexion gap and utilized a sleeve and offset bolt to further help manage the loose flexion gap.After doing a trial reduction the patient was stable in flexion and extension.The patients tibia implants were all left in situ and were not revised.Doi: (b)(6) 2019; dor: (b)(6) 2019; left knee.

Manufacturer Narrative

Product complaint # (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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).Investigation summary: 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: SIGMA FEM ADAPTER NEUTRAL BOLT
• Type of Device: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9532202
• MDR Text Key: 174707026
• Report Number: 1818910-2019-124953
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295233930
• UDI-Public: 10603295233930
• Combination Product (y/n): N
• PMA/PMN Number: K060515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2019

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
• Device Operator: Health Professional
• Device Model Number: 96-0783
• Device Catalogue Number: 960783
• Device Lot Number: HD9728
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 12/09/2019; 01/30/2020
• Supplement Dates FDA Received: 01/08/2020; 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR CEMENT; UNKNOWN KNEE TIBIAL TRAY
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR