MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number	150600004
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).E3 initial reporter occupation: (b)(6).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
Litigation records ad 22 apr 2024 were reviewed by clinician.On (b)(6) 2017 the patient had bilateral knee arthroplasties to address severe primary osteoarthritis.Depuy components were implanted during these procedure, including depuy patella and depuy cement x2.On (b)(6) 2023, the patient had a left knee revision to address mechanical failure of the prosthetic left knee joint.During the procedure, the surgeon noted there was a large amount of scar tissue, there was extensive thickness of the patella and it was removed.There was evidence of loosening of the tibial tray component with separation of the tibial tray from the cement mantle.All components were removed and competitor components were implanted during this procedure.Doi: (b)(6) 2017.Dor: (b)(6) 2023.(left knee).
Event or Problem Description
Medical records were received: on (b)(6) 2017 the patient had bilateral knee arthroplasties to address severe primary osteoarthritis.Depuy components were implanted during these procedure, including depuy patella and depuy cement x2 (left knee sticker sheet page 7 of 16)(right knee sticker sheet page 16 of 16).On (b)(6) 2023, the patient had a left knee revision to address the mechanical failure of the prosthetic left knee joint.During the procedure, the surgeon noted there was a large amount of scar tissue, there was extensive thickness of the patella and it was removed.There was evidence of loosening of the tibial tray component with separation of the tibial tray from the cement mantle.All components were removed and competitor components were implanted during this procedure.Doi: (b)(6) 2017.Dor: (b)(6) 2023.Left 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.

• Brand Name: ATTUNE FB TIB BASE SZ 4 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19277485
• Report Number: 1818910-2024-10233
• Device Sequence Number: 7659856
• Product Code: JWH
• UDI-Device Identifier: 10603295042389
• UDI-Public: 10603295042389
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 05/09/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 150600004
• Device Lot Number: 6602501
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 DOME PAT 35MM.; ATTUNE PS FB INSRT SZ 5 6MM.; ATTUNE PS FEM LT SZ 6 NAR CEM.; SMARTSET GMV 40G US EO.; SMARTSET GMV 40G US EO.; TRUMATCH ATTUNE KIT LEFT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female