MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number	1506-00-006
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Adhesion(s) (1695); Loss of Range of Motion (2032)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.Component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
On (b)(6) 2017, the patient had a left total knee arthroplasty to address primary end-stage valgus degenerative joint disease.Depuy components, including depuy patella, and depuy cement x1 were implanted during this procedure.On (b)(6) 2022, the patient had a revision left total knee to address failed left total knee, arthrofibrosis, limited range of motion, and aseptic loosening of the tibial tray.During the procedure, the surgeon observed that the tibial tray had debonded from the cement.The femoral component and insert were revised with no allegation of deficiency.Competitor components were implanted during this procedure.Doi :(b)(6) 2017 dor: (b)(6) 2022 (left knee).This is a link of (b)(4).

• Brand Name: ATTUNE FB TIB BASE SZ 6 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16831071
• Report Number: 1818910-2023-08948
• Device Sequence Number: 7095820
• Product Code: JWH
• UDI-Device Identifier: 10603295042402
• UDI-Public: 10603295042402
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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 Model Number: 1506-00-006
• Device Catalogue Number: 150600006
• Device Lot Number: 8466785
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2017
• 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 FB INSRT SZ 5 6MM; ATTUNE CR FEM LT SZ 5 NAR CEM; ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE MEDIAL DOME PAT 38MM; SMARTSET HV BONE CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female