MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI FEMORAL SZ3 LM/RL; EARLY INTERVENTION : KNEE FEMORAL

Model Number 1024-07-300

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

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 04/29/2021

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 underwent primary right lateral unicompartmental knee replacement on (b)(6) 2008 where a sigma partial was utilised.Patient has presented with a progressively more painful knee and has reported feelings of instability on the lateral side.On opening the knee ((b)(6) 2021 (b)(6)) all components were found to be well fixed.Reason for revision was progression of disease and pain.Components were removed and a right primary attune ps rp implanted.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SIGMA HP UNI FEMORAL SZ3 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: 11831661
• MDR Text Key: 250837035
• Report Number: 1818910-2021-10404
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295001737
• UDI-Public: 10603295001737
• Combination Product (y/n): N
• PMA/PMN Number: K070849
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1024-07-300
• Device Catalogue Number: 102407300
• Device Lot Number: B1SXF4000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIGMA HP UNI FEMORAL SZ3 LM/RL; SIGMA HP UNI INS SZ3 7MM LM/RL; SIGMA HP UNI TIB TRAY SZ3 LMRL; SIGMA HP UNI FEMORAL SZ3 LM/RL; SIGMA HP UNI INS SZ3 7MM LM/RL; SIGMA HP UNI TIB TRAY SZ3 LMRL
• Patient Outcome(s): Required Intervention