MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 5 CEM; KNEE TIBIAL TRAY

Catalog Number	150680005
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient has experienced tibial subsidence and loosening requiring revision of all attune implants to attune revision in a single stage revision procedure.The cement that was used was cmw2, 2 separate mixes for tibia then femur.All implants removed; multiple tissue samples taken.Patient then reprepped and draped and definitive revision procedure carried out.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, 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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary :no device associated with this report was received for examination.A search of the j&j medtech orthopaedics nonconformance (nc) quality system found no nc¿s associated with this product 150680005/lot 9438712 combination.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 : a search of the j&j medtech orthopaedics nonconformance (nc) quality system found no nc¿s associated with this product 150680005/lot 9438712 combination.

• Brand Name: ATTUNE RP TIB BASE SZ 5 CEM
• Common Device Name: 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: 21078447
• Report Number: 1818910-2025-00207
• Device Sequence Number: 6899160
• Product Code: NJL
• UDI-Device Identifier: 10603295492177
• UDI-Public: (01)10603295492177(17)300131(10)9438712
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 150680005
• Device Lot Number: 9438712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2021
• 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 MEDIAL ANAT PAT 32MM; ATTUNE PS FEM RT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 8MM; UNKNOWN BONE CEMENT; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 123 KG