MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 6 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/07/2017
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 was reviewed.On (b)(6) 2016, the patient had a conversion from uni-compartmental arthroplasty of the right knee to total knee arthroplasty.Indications for surgery included pain.During the procedure the knee joint revealed severe tricompartmental arthritic changes and uni-compartmental medially there was loosening.Depuy components including depuy patella and depuy cement x2 were used during this procedure.There was no mention of the manufacturer of the previously implanted uni.On (b)(6) 2017, the patient had a revision right total knee arthroplasty to right infected total knee.All components including the patella were revised.Depuy components were implanted during this procedure, including depuy cement x3.Doi: (b)(6) 2016.Dor: (b)(6) 2017 (right 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 release for distribution.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 PS FB INSRT SZ 6 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11413537
• Report Number: 1818910-2021-04386
• Device Sequence Number: 14320522
• Product Code: NJL
• UDI-Device Identifier: 10603295050100
• UDI-Public: 10603295050100
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• 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: No Information
• Device Expiration Date: 09/30/2019
• Device Model Number: 1516-40-610
• Device Catalogue Number: 151640610
• Device Lot Number: 589594
• 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: 04/07/2021
• 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 5 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FB INSRT SZ 6 10MM; ATTUNE PS FEM RT SZ 6 NAR CEM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G; ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FB INSRT SZ 6 10MM; ATTUNE PS FEM RT SZ 6 NAR CEM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR