MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ3 10MM LMRL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number	1024-53-310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.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 unicompartmental left medial knee replacement on (b)(6) 2020 (b)(6) hospital.Patient returned for a revision of the tibial component on (b)(6) 2021 (b)(6) hospital.See (b)(4) at this stage the tibial component was loose.The bone was prepared and another tibial component and insert were implanted.Patient has been doing very well and reported waking up on sunday (b)(6) 2021 with a painful knee.The knee has become increasingly painful over the next 24 hours and the patient has now presented to (b)(6) hospital.A decision was made to open the knee as infection was suspected.On opening the knee (b)(6) hospital (b)(6) 2021.The joint was full of puss.The knee was washed out several times with a range of solutions.The tibial bearing was removed and a new bearing inserted.Infection requiring washout and exchange.

• Brand Name: SIGMA HP UNI INS SZ3 10MM LMRL
• 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: 12496821
• Report Number: 1818910-2021-20512
• Device Sequence Number: 11532860
• Product Code: HRY
• UDI-Device Identifier: 10603295002567
• UDI-Public: 10603295002567
• 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: 2021
• 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
• Report Date (Section B): 08/30/2021

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: 1024-53-310
• Device Catalogue Number: 102453310
• Device Lot Number: J1976C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/20/2021
• 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 SZ4 LM/RL; SIGMA HP UNI INS SZ3 10MM LMRL; SIGMA HP UNI TIB TRAY SZ3 LMRL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR