MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ4 7MM LM/RL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number 1024-53-407

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

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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

The patient was revised to address pain and loosening of an unknown component.Unknown cement was used.On (b)(6) 2019, the patient underwent a primary left knee arthroplasty with implantation of depuy unicondylar sled prothesis to treat osteoarthritis.Depuy cement was utilized during the procedure.The patella was not resurfaced.There were no indicated intra-operative complications.On (b)(6) 2020, the patient underwent a left knee revision to address pain, adhesion, cysts, crepitus, and tibial tray loosening at the cement to implant interface.All components were removed, and the patella was resurfaced.Depuy products were implanted with depuy cement.On (b)(6) 2021, a left knee x-ray revealed osteolysis beneath the tibial plateau.On (b)(6) 2021, a left knee ct revealed possible tibial tray loosening.On (b)(6) 2021, the patient underwent a left knee aspiration to rule out infection due to increasing pain.The physician aspirated 15 ml of blood-tinged clear effusion and sent for microbiology and cell count.Results of aspiration not given within the available medical records.The physician also indicated a request for allergy testing for the bone cement.No results available regarding an allergy to bone cement.Doi: 2019, dor: unknown.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.This device was manufactured on 18-sept-2017.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.Device history lot : 1) quantity manufactured: (b)(4).2) date of manufacture: 18-sep-2017, 3) any anomalies or deviations identified in dhr: none, 4) expiry date: 31-aug-2022, 5) ifu reference: 090200806.

• Brand Name: SIGMA HP UNI INS SZ4 7MM LM/RL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11619149
• MDR Text Key: 243936028
• Report Number: 1818910-2021-07124
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002581
• UDI-Public: 10603295002581
• Combination Product (y/n): N
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1024-53-407
• Device Catalogue Number: 102453407
• Device Lot Number: HG4810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIGMA HP UNI FEMORAL SZ4 LM/RL; SIGMA HP UNI INS SZ4 7MM LM/RL; SIGMA HP UNI TIB TRAY SZ4 LMRL; SMARTSET GHV GENTAMICIN 20G; SIGMA HP UNI FEMORAL SZ4 LM/RL; SIGMA HP UNI INS SZ4 7MM LM/RL; SIGMA HP UNI TIB TRAY SZ4 LMRL; SMARTSET GHV GENTAMICIN 20G
• Patient Outcome(s): Required Intervention