MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE PS FB INSRT SZ 8 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151640805
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left knee revision to treat pain and joint instability secondary to aseptic loosening of the tibial tray.Upon entering the joint, the tibial tray was found to be loosened and debounded at the competitor cement to implant interface.There was no reported product problem with the revised tibial insert.The femoral component and patella were well-fixed and retained.The patient received an attune revision construct secured with competitor cement.The procedure was completed without complications.
Additional Manufacturer Narrative
Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: e3 initial reporter occupation: lawyer.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product description: attune ps fb insrt sz 8 5mm.Product code: 151640805.Lot number: 357884.Quantity manufactured: (b)(4).Manufacturing date: 21-mar-2013.Date of expiry: 31-mar-2018.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: product description: attune ps fb insrt sz 8 5mm.Product code: 151640805.Lot number: 357884.Quantity manufactured: (b)(4).Manufacturing date: 21-mar-2013.Date of expiry: 31-mar-2018.Device history review: a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: added: d10.

• Brand Name: ATTUNE PS FB INSRT SZ 8 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22087742
• Report Number: 1818910-2025-08498
• Device Sequence Number: 12734013
• Product Code: JWH
• UDI-Device Identifier: 10603295050346
• UDI-Public: (01)10603295050346(17)180331(10)357884
• Combination Product (Y/N): N
• 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,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 03/31/2018
• Device Catalogue Number: 151640805
• Device Lot Number: 357884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2013
• 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 7 CEM.; ATTUNE MEDIAL DOME PAT 38MM.; ATTUNE MEDIAL DOME PAT 38MM.; ATTUNE PS FB INSRT SZ 8 5MM.; ATTUNE PS FEM LT SZ 8 CEM.; ATTUNE PS FEM LT SZ 8 CEM.; BONE CEMENT - COMPETITOR.; BONE CEMENT STRYKER MEDICAL.; FIBERWIRE METALLIC HARDWARE - COMPETITOR.; FIBERWIRE METALLIC HARDWARE ARTHREX.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male