MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE KNEE SYSTEM TIBIAL BASE FIXED BEARING SIZE 4 CEMENTED; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number	150600004
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint#: (b)(4).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
It was reported that a 55-year-old female patient received a second right knee revision to treat pain, swelling, and instability secondary to loosening and migration of the tibial tray.The patient had a previous revision of the tibial insert to treat instability and poly-wear on (b)(6) 2019.Upon entering the joint, the surgeon confirmed the tibial tray was migrated and grossly loose at the competitor cement to implant interface.The femoral component was well-fixed and retained.There was no reported product problem with the revised unknown tibial insert.The patella was well-fixed with mild wear but retained.The patient received a depuy attune stemmed revision construct secured with competitor cement.The procedure was completed without complications.This pc was linked to (b)(4) left knee first revision, (b)(4) left knee second revision.(b)(4) right knee first revision.Doi: on (b)(6) 2014, dor: on (b)(6) 2019 (primary tibial insert captured on (b)(4), dor: on (b)(6) 2023 (unk insert and tibial tray), right knee.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.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 records evaluation (mre) was not perform.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: 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.Added: d10 concomitant.

• Brand Name: ATTUNE KNEE SYSTEM TIBIAL BASE FIXED BEARING SIZE 4 CEMENTED
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21201336
• Report Number: 1818910-2025-01254
• Device Sequence Number: 8341798
• Product Code: JWH
• UDI-Device Identifier: 10603295042389
• UDI-Public: (01)10603295042389(17)240731(10)7973304
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 07/31/2024
• Device Catalogue Number: 150600004
• Device Lot Number: 7973304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2014
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE PS FEM RT SZ 5 CEM.; STRYKER BONE CEMENT (COMPETITOR).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female