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

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

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/30/2021

Event Type  Injury  

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 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
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12496821
• MDR Text Key: 272200654
• Report Number: 1818910-2021-20512
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002567
• UDI-Public: 10603295002567
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1024-53-310
• Device Catalogue Number: 102453310
• Device Lot Number: J1976C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SIGMA HP UNI FEMORAL SZ4 LM/RL; SIGMA HP UNI INS SZ3 10MM LMRL; SIGMA HP UNI TIB TRAY SZ3 LMRL
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR