MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-00-003

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2020

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient had a left total knee arthroplasty to address osteoarthritis.Depuy component, including depuy patella, and depuy cement x2 were used during this procedure.On (b)(6) 2020, the patient had a left total knee revision to address loose tibial component.The surgeon reported that the femoral component was in slight valgus, which needed to be corrected and it was revised.The tibial component was noted to be grossly loose.Loosening was noted to be at the cement/implant interface.The insert was revised with no allegation of deficiency.The patella was not revised.Doi: (b)(6) 2014.Dor: (b)(6) 2020.(left knee).

Manufacturer Narrative

Product complaint # (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.

Manufacturer Narrative

Product complaint # (b)(4).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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE FB TIB BASE SZ 3 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12825006
• MDR Text Key: 280962431
• Report Number: 1818910-2021-25278
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042372
• UDI-Public: 10603295042372
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506-00-003
• Device Catalogue Number: 150600003
• Device Lot Number: 7855473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2014
• 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 3 CEM; ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FB INSRT SZ 4 6MM; ATTUNE PS FEM LT SZ 4 CEM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female