MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI FEMORAL SZ2 LM/RL; EARLY INTERVENTION : KNEE FEMORAL

Model Number 1024-07-200

Device Problems Loss of or Failure to Bond (1068); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 04/07/2021

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

Revision of a depuy sigma uni knee replacement.Reason for revision was due to medial collapse/loosening of implants.All implants were removed and an attune total knee was implanted.Implants not available for return.

• Brand Name: SIGMA HP UNI FEMORAL SZ2 LM/RL
• Type of Device: EARLY INTERVENTION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11711675
• MDR Text Key: 247045470
• Report Number: 1818910-2021-08477
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 10603295001720
• UDI-Public: 10603295001720
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1024-07-200
• Device Catalogue Number: 102407200
• Device Lot Number: J00R45
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIGMA HP UNI INS SZ2 7MM LM/RL; SIGMA HP UNI TIB TRAY SZ2 LMRL; SIGMA HP UNI INS SZ2 7MM LM/RL; SIGMA HP UNI TIB TRAY SZ2 LMRL
• Patient Outcome(s): Required Intervention