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

Catalog Number	150610005
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Ambulation or Postural Difficulties (2544); Unspecified Musculoskeletal problem (4535)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4).E3 initial reporter occupation: lawyer.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.
Event or Problem Description
The patient underwent a right primary knee replacement on (b)(6) 2016 utilizing attune implants with no indication of cement manufacturer.On (b)(6) 2023, the patient began to have pain and was limping.Xray review identified gross loosening and early collapse of the right tibia.On (b)(6) 2023, the patient was revised and the tray was confirmed to be loose at the implant to cement interface.Doi: (b)(6) 2016.Dor: (b)(6) 2023 (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.
Event or Problem Description
Additional information was received: during the revision surgery, hypertrophied synovium "consistent with cement type of disease" was identified.There was cement debris identified within the joint space.There was wear into both the medial and lateral distal femoral condyles of the femoral component with concerns for loosening so the femoral component was revised.Confirmation of loosening and/or loosening interface was not clearly stated.On the tibial side, scarring and bony overgrowth was removed.The tibial base was grossly loose at the cement to implant interface and subsided.There was a "deficiency" in the tibial membrane that was sent for cultures.

• Brand Name: ATTUNE RP TIB BASE SZ 5 CEM
• 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 46581-0988 ; 3035526892
• MDR Report Key: 18825094
• Report Number: 1818910-2024-04885
• Device Sequence Number: 7935336
• Product Code: NJL
• UDI-Device Identifier: 10603295042594
• UDI-Public: 10603295042594
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 150610005
• Device Lot Number: 8212661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2015
• 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 PS RP INSRT SZ6 6MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female