MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 3 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-305
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Joint Laxity (4526)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Patient received a right primary attune to treat severe osteoarthritis.The patella was resurfaced and depuy cement x1 was utilized.The procedure was completed without complications.Patient¿s right knee was revised to treat pain and instability secondary to suspected tibial tray loosening.Upon entering the joint, the surgeon identified and excised periarticular scar tissue.The tibial tray was loosened and debonded at the cement to implant interface and revised.The femoral component was well-fixed but revised to accommodate the revision products.There was no reported product problem with the revised tibial insert.The patella was retained.The patient was revised with a competitor revision knee construct.The procedure was completed without complications.Doi: (b)(6) 2014, dor: (b)(6) 2020, right 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 CR FB INSRT SZ 3 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12363704
• Report Number: 1818910-2021-18562
• Device Sequence Number: 4633171
• Product Code: NJL
• UDI-Device Identifier: 10603295045403
• UDI-Public: 10603295045403
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• 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): 08/06/2021

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: 05/05/2017
• Device Model Number: 1516-20-305
• Device Catalogue Number: 151620305
• Device Lot Number: 251992
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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 3 5MM; ATTUNE CR FEM RT SZ 3 CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 32MM; SMARTSET MV 40G - EO; ATTUNE CR FB INSRT SZ 3 5MM; ATTUNE CR FEM RT SZ 3 CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 32MM; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR