MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 4 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Local Reaction (2035); Synovitis (2094)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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) 2014, the patient had a left total knee arthroplasty to address osteoarthritis.Depuy components including depuy patella were used during this procedure.Competitor cement was used.No complications were noted in the operative notes.On (b)(6) 2018, the patient had a revision to address pain and loosening of the tibial tray, no interface provided.During the procedure, the surgeon observed hypertrophic synovium with a grayish black pigmentation, and extensive synovitis.The patella was noted to be stable with mild hypertrophic discolored synovium around the patella component, but was not revised.The tibial tray, femoral component and insert were revised.Doi: (b)(6) 2018; dor: (b)(6) 2018; (left knee).
Additional Manufacturer Narrative
Product complaint # : pc-(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.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 4 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11447482
• Report Number: 1818910-2021-04780
• Device Sequence Number: 4092151
• Product Code: NJL
• UDI-Device Identifier: 10603295049821
• UDI-Public: 10603295049821
• 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: 2014
• 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): 02/25/2021

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: 04/30/2018
• Device Model Number: 1516-40-410
• Device Catalogue Number: 151640410
• Device Lot Number: 363964
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/21/2021
• 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; ATTUNE PS FB INSRT SZ 4 10MM; ATTUNE PS FEM LT SZ 4 CEM; PALACOS RADIOPAQUE BONE CEMNT WITH GENTAMICIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR