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 Problem No Code Available (3191)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6) 2014: the patient underwent a bilateral total knee arthroplasty for osteoarthritis.Attune implants were utilized with depuy cement x2 for left knee and depuy cement x2 for right knee.Patella was resurfaced for both knees.No intraoperative complications were noted.On (b)(6) 2019: the patient underwent right knee revision due to suspected aseptic tibial tray loosening.Intraoperatively, the surgeon found the tibial tray loose at implant-cement interface.Patella and femoral components were not revised.All other components (tibial ray and insert) were explanted and replaced with depuy revision knee system with depuy cement.This complaint captures the right knee.Doi: (b)(6) 2014.Dor of right: (b)(6) 2019, (tibial tray and insert).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: product complaint # :(b)(4).Investigation summary :no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• MDR Report Key: 9556080
• MDR Text Key: 173970374
• Report Number: 1818910-2020-00714
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042389
• UDI-Public: 10603295042389
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 1506-00-004
• Device Catalogue Number: 150600004
• Device Lot Number: 4723500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 35MM.; ATTUNE PS FB INSRT SZ 6 7MM.; ATTUNE PS FEM RT SZ 6 NAR CEM.; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 6 7MM; ATTUNE PS FEM RT SZ 6 NAR CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR