MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA XLK CVD PLUS INS 2 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number 97-0430

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

Patient Problems Joint Disorder (2373); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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

The following implants were removed today during revision knee replacement surgery.960018 2.5 rt cr femur.Lot d18112858.970430.Sz 2 8mm curved plus insert.Lot hy9752.Fixed flexion deformity was the reason for revision.

Manufacturer Narrative

Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

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.

• Brand Name: SIGMA XLK CVD PLUS INS 2 8MM
• Type of Device: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10764618
• MDR Text Key: 214128230
• Report Number: 1818910-2020-23717
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295250425
• UDI-Public: 10603295250425
• Combination Product (y/n): N
• PMA/PMN Number: K943299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2020

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: 97-0430
• Device Catalogue Number: 970430
• Device Lot Number: HY9752
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 11/04/2020; 01/05/2021
• Supplement Dates FDA Received: 11/12/2020; 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PFC SIGMA C/R NPOR FE RT SZ2.5.
• Patient Outcome(s): Required Intervention