MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 6 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-607
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.(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.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 indicate a patient underwent a right total knee arthroplasty utilizing attune implants.The patella was resurfaced and smartset gmv cement was used.Patient was later revised for global instability and tibial component malalignment.While the surgeon states the tibial component was easy to remove, he states the femoral, patella, and tibial tray were all well-fixed.The femoral component, insert, and tray were revised.Doi: (b)(6) 2015.Dor: (b)(6) 2022.(right knee).

• Brand Name: ATTUNE CR FB INSRT SZ 6 7MM
• 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: 15969980
• Report Number: 1818910-2022-25232
• Device Sequence Number: 5526180
• Product Code: JWH
• UDI-Device Identifier: 10603295045786
• UDI-Public: 10603295045786
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 12/13/2022

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: 11/30/2019
• Device Model Number: 1516-20-607
• Device Catalogue Number: 151620607
• Device Lot Number: 602744
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2014
• 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 CR FB INSRT SZ 6 7MM; ATTUNE CR FEM RT SZ 6 CEM; ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 38MM; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female