MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE PS FEM RT SZ 6 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150410206
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Synovitis (2094)
Date of Event	04/06/2022
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
Litigation complaint received ad 2 feb 2024.Doi: on (b)(6) 2015, dor: on (b)(6) 2022.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.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 device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.Added: b5.
Event or Problem Description
Medical records ad 2 feb 2024 was reviewed by the clinician.On (b)(6) 2015 the patient had a right knee arthroplasty to address right nee severe varus osteoarthritis with flexion contracture.Depuy components were placed at this time.*on (b)(6) 2015 the patient had a manipulation under anesthesia to address arthrofibrosis right knee.*on (b)(6) 2022 the patient had a revision right knee to address a failed right knee with loose tibial component debonding at cement/implant interface, medical tibial bone loss, and severe varus positioning.The indications for surgery included subsidence of the tibial component along with progressive deformity and worsening function.During the procedure, the surgeon observed extensive amounts of very inflamed synovium.The tibial tray was found to be grossly loose.The femoral component was well positioned and fixed but was revised as the knee was being switched to competitor products.The patella was well fixed and positioned, and it was left in situ.Competitor products, including competitor cement, were utilized during this procedure.Doi: (b)(6) 2015 dor: (b)(6) 2022 right knee.

• Brand Name: ATTUNE PS FEM RT SZ 6 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18753984
• Report Number: 1818910-2024-03868
• Device Sequence Number: 14384908
• Product Code: JWH
• UDI-Device Identifier: 10603295041771
• UDI-Public: 10603295041771
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• 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): 02/21/2024

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: 150410206
• 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: 02/02/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 02/23/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE FB TIB BASE SZ 5 CEM.; ATTUNE PS FB INSRT SZ 6 5MM.; SMARTSET GHV GENTAMICIN 40G.; SMARTSET HV BONE CEMENT 40G.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female