MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 4 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-405
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
Medical records ad 02 feb 2021 were reviewed.On (b)(6) 2015, the patient had a left total knee arthroplasty to address left tricompartmental knee osteoarthritis.No complications were noted during this procedure.Depuy components, including depuy patella and depuy cement x2 were used.On (b)(6) 2018, the patient had a revision to address aseptic loosening.The indications for surgery included worsening pain, instability and preoperative radiographs were reported to show displacement of the tibial component with evidence of loosening of the femoral component.During the procedure, the surgeon observed, abundant synovitis, extensive erosions around the joint implants, the femoral component was loose at the component/cement interface.The tibial tray was loose at the component/cement interface.There was large erosions/bone loss.Competitor components were implanted during this procedure.There was no allegation of deficiency for the patella, and no mention of revising it.Doi: (b)(6) 2015.Dor: (b)(6) 2018 (left knee).
Additional 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 01-jan-2015.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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 : 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE CR FB INSRT SZ 4 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11413754
• Report Number: 1818910-2021-04400
• Device Sequence Number: 14320524
• Product Code: JWH
• UDI-Device Identifier: 10603295045526
• UDI-Public: 10603295045526
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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 Expiration Date: 08/31/2018
• Device Model Number: 1516-20-405
• Device Catalogue Number: 151620405
• Device Lot Number: 422519
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/08/2021
• 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: ATTUNE CR FB INSRT SZ 4 5MM; ATTUNE CR FEM LT SZ 4 CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL ANAT PAT 35MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; ATTUNE CR FB INSRT SZ 4 5MM; ATTUNE CR FEM LT SZ 4 CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL ANAT PAT 35MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR