MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 5 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Synovitis (2094)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.Component code: appropriate term/code not available (g07002) used to capture no findings available.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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
Litigation complaint received ad 24 feb 2023.Patient received a right primary attune knee.The patella was resurfaced, and unknown cement was utilized.Male patient received a right knee revision to treat a failed tka.Upon entering the joint, the surgeon identified and debrided synovitis and foreign body reaction.The tibial tray was grossly loose and debonded at the cement to implant interface and had migrated into varus.The surgeon notes tibial bone loss after the tray was removed.The femoral component was well-fixed but revised to accommodate the revision knee construct.The patella was well-fixed and retained.There was no reported product problem with the revised tibial insert.The patient received a tc3 revision knee.The procedure was completed without complications.Doi: (b)(6) 2017.Dor: (b)(6) 2022, right knee.

• Brand Name: ATTUNE PS FB INSRT SZ 5 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16536510
• Report Number: 1818910-2023-05728
• Device Sequence Number: 5945942
• Product Code: JWH
• UDI-Device Identifier: 10603295049968
• UDI-Public: 10603295049968
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2023

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: 12/31/2021
• Device Model Number: 1516-40-510
• Device Catalogue Number: 151640510
• Device Lot Number: H32389
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 5 10MM; ATTUNE PS FEM RT SZ 5 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male