MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRAY SZ4 LMRL; EARLY INTERVENTION : KNEE TIBIAL TRAY

Catalog Number 102451400

Device Problems Loss of or Failure to Bond (1068); 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

Product complaint # (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.Doi: 2019.Dor: unknown; unknown affected side.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records received were reviewed: 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.Revision is captured on (b)(4).Task created to update pc.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.Task created to update (b)(4) with information involving events from (b)(6) 2021.There is no evidence of a second revision involving the left knee.

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 14-feb-2019.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: 2/14/19.3) any anomalies or deviations identified in dhr: na.4) expiry date: 1/31/2029.5) ifu reference: rev e.

• Brand Name: SIGMA HP UNI TIB TRAY SZ4 LMRL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11446014
• MDR Text Key: 238660060
• Report Number: 1818910-2021-04733
• Device Sequence Number: 1
• Product Code: HRY
• 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,Followup,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102451400
• Device Lot Number: J24J19
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2021
• 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; SMARTSET GHV GENTAMICIN 20G; UNKNOWN KNEE IMPLANT; UNKNOWN KNEE IMPLANT
• Patient Outcome(s): Required Intervention