MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 8 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-00-008

Device Problems Loss of or Failure to Bond (1068); Migration (4003)

Patient Problems Muscular Rigidity (1968); Pain (1994)

Event Date 07/07/2022

Event Type  Injury  

Event Description

Clinical notification received for revision due to aseptic loosening, pain, and stiffness.Date of implant: (b)(6) 2013.Date of revision: (b)(6) 2022.(left knee).Treatment: revision; femoral component, tibial, and insert were removed.

Manufacturer Narrative

Product complaint # (b)(4).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.

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.H10 additional narrative: added: b5.

Event Description

Operative notes received: on (b)(6) 2013, the patient had a left total knee implant to address osteoarthritis of the left knee.Depuy components, including depuy patella were used during this procedure.On (b)(6) 2022, the patient had a revision left total knee to address failure of fixation of the tibial component.The components implanted were depuy, the indications for surgery included: tibial tray loosening, tibial tray settling into varus, pain, deformity of the leg.During the procedure the surgeon observed that the tibial tray had debonded from the cement and settled into varus.The femoral component was well fixed, but revised to facilitate exposure.

• Brand Name: ATTUNE FB TIB BASE SZ 8 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: 15321062
• MDR Text Key: 298892738
• Report Number: 1818910-2022-16888
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042426
• UDI-Public: 10603295042426
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

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
• Device Operator: Health Professional
• Device Model Number: 1506-00-008
• Device Catalogue Number: 150600008
• Device Lot Number: 3615462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2013
• 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 8 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 8 6MM; ATTUNE PS FEM LT SZ 8 CEM; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic