MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 5 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-00-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Synovitis (2094); Joint Laxity (4526)
Date of Event	05/29/2020
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 25 nov 2020 was reviewed.On (b)(6) 2016, the patient had a left knee arthroplasty to address severe degenerative joint disease.Depuy components including depuy patella and depuy cement.On (b)(6) 2020, the patient had a revision left total knee arthroplasty, femoral and tibial implants, to address failed left total knee, instability, and aseptic loosening.During the procedure the surgeon observed diffuse hypertrophic synovitis.There was gross loosening of the femoral component and tibial tray component at the bone to cement interface for both.The patella was left in-situ.Competitor components were implanted.Doi: (b)(6) 2016.Dor: (b)(6) 2020 (left knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 h10 additional narrative: added: g2.

• Brand Name: ATTUNE CR FEM LT SZ 5 NAR CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11055997
• Report Number: 1818910-2020-27452
• Device Sequence Number: 14172091
• Product Code: JWH
• UDI-Device Identifier: 10603295041146
• UDI-Public: 10603295041146
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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: 11/30/2024
• Device Model Number: 1504-00-125
• Device Catalogue Number: 150400125
• Device Lot Number: 8036470
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/27/2021
• 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 5 5MM; ATTUNE CR FEM LT SZ 5 NAR CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR