MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-00-004

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Pain (1994); Synovitis (2094); Ambulation Difficulties (2544)

Event Date 10/18/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.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.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.

Event Description

Medical records received ad 15 dec 2022 were reviewed by clinician.On (b)(6) 2016 the patient had a left knee replacement to address end-stage degenerative joint disease left knee.Depuy components were implanted during this procedure along with competitor cement.On (b)(6) 2022 radiographs were noted to show lucency adjacent to the tibial component and osteophyte formation along the superior pole of the patella.Patient reported having pain.On (b)(6) 2022, the patient had a revision to address left total knee arthroplasty failure secondary to aseptic loosening.The patient had been experiencing pain and difficulty walking.During the procedure the surgeon observed that the tibial component was grossly loose (no interface), cement breakdown, synovitis, fibrinous tissue under tibial baseplate.The tibial tray, insert, and femoral component were revised.The patella was retained.Competitor components were implanted during this procedure, including competitor cement.Doi: (b)(6) 2016.Dor: (b)(6) 2022.(left knee).

• Brand Name: ATTUNE FB TIB BASE SZ 4 CEM
• Type of Device: 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: 16101523
• MDR Text Key: 306684372
• Report Number: 1818910-2023-00432
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042389
• UDI-Public: 10603295042389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506-00-004
• Device Catalogue Number: 150600004
• Device Lot Number: 8368831
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 6 8MM; ATTUNE PS FEM LT SZ 6 NAR CEM; HOWMEDICA SIMPLEX CEMENT; HOWMEDICA SIMPLEX CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female