MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ3 7MM LM/RL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number	1024-53-307
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 INS SZ3 7MM LM/RL
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11831682
• Report Number: 1818910-2021-10405
• Device Sequence Number: 3172874
• Product Code: HRY
• UDI-Device Identifier: 10603295002536
• UDI-Public: 10603295002536
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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 Model Number: 1024-53-307
• Device Catalogue Number: 102453307
• Device Lot Number: B5GH91000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 07/13/2021
• 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: 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
• Outcome Attributed to Adverse Event: Required Intervention