MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE RP TIB BASE SZ 6 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number	150610006
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Litigation complaint received ad 5 jun 2024.On (b)(6) 2017, the patient had a right knee arthroplasty to address degenerative arthritis.Depuy components were placed during this procedure, including depuy cement and patella.On (b)(6) 2023, the patient had a right total knee revision to address aseptic loosening of the right total knee and femoral osteolysis.Prior to surgery, the patient was reported to have had pain, decrease range of motion, stiffness, fibrosis, declining function.During the procedure, the surgeon reported finding osteolysis of the femur and no cement adhered to back of the tibial tray.(loosening) osteophytes were removed from the patella.Competitor components were implanted during this procedure, including competitor cement.Update ad 5 jun2024: update event description: on (b)(6) 2017, the patient had a right knee arthroplasty to address degenerative arthritis.Depuy components were placed during this procedure, including depuy cement and patella.(b)(6) 2022 medical records note right knee pain and dysfunction after tka, as well as left knee pain (no implant) right knee pain, swelling, decrease range of motion, stiffness.Patient had a previous injection to calm down inflammation.An aspiration is scheduled.(b)(6) 2022 right knee pain, an aspiration was negative for infection.On (b)(6) 2023, the patient had a right total knee revision to address aseptic loosening of the right total knee and femoral osteolysis.Prior to surgery, the patient was reported to have had pain, decrease range of motion, stiffness, fibrosis, declining function.During the procedure, the surgeon reported finding osteolysis of the femur and no cement adhered to back of the tibial tray.(loosening) osteophytes were removed from the patella.Competitor components were implanted during this procedure, including competitor cement.Doi: (b)(6) 2017 dor: (b)(6) 2023 (right knee).
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.
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 product/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.

• Brand Name: ATTUNE RP TIB BASE SZ 6 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: 19567939
• Report Number: 1818910-2024-13309
• Device Sequence Number: 20368546
• Product Code: NJL
• UDI-Device Identifier: 10603295042600
• UDI-Public: (01)10603295042600
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• 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): 06/19/2024

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 Catalogue Number: 150610006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 CR FEM RT SZ 6 CEM.; ATTUNE CR RP INSRT SZ 6 6MM.; ATTUNE MEDIAL DOME PAT 38MM.; SMARTSET HV BONE CEMENT 40G.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male