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

Model Number	1504-10-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.(b)(4).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
(b)(4) medical records ad 24 may 2021 were reviewed 06/07/2021.On (b)(6) 2017, the patient had a left total knee arthroplasty.Depuy components, including depuy patella and depuy cement x1.On (b)(6) 2018, the patient had a removal of prosthesis, total knee arthroplasty to address, infection, and loose tibial component.Prior to surgery, the patient was noted to have had pain.During the procedure, the surgeon observed significant purulence, synovitis, and tibial tray loosening at the implant/cement interface.Competitor components were used during this procedure.Doi: (b)(6) 2017 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.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.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE PS 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: 11995411
• Report Number: 1818910-2021-12583
• Device Sequence Number: 922243
• Product Code: JWH
• UDI-Device Identifier: 10603295041702
• UDI-Public: 10603295041702
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 06/07/2021

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 Model Number: 1504-10-125
• Device Catalogue Number: 150410125
• Device Lot Number: 8005469
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 07/17/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/19/2021
• 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 FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FB INSRT SZ 5 6MM; ATTUNE PS FEM LT SZ 5 NAR CEM; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR