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

Model Number	1506-00-003
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported that the patient's knee was revised due to aseptic tibial loosening and subsidence at cement to implant interface.The patient's primary attune fixed bearing tibial base and cruciate retaining fixed bearing insert were removed and replaced by attune revision components.There was no cement attached to the underside of the tibial base, which would suggest that there was a flaw in the design of the tibial base according to the surgeon depuy smartset gmv bone cement was use during the primary procedure.The lot numbers for the cement used is not available, since it was ordered directly from depuy by the hospital.Doi: (b)(6) 2017.Dor: (b)(6) 2023.Affected side : left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was returned to depuy synthes for evaluation.Visual examination found signs of micromotion on the bottom surface of the device, confirming the reported allegation of loosening, however not enough evidence of device migration was found.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16770935
• Report Number: 1818910-2023-08230
• Device Sequence Number: 6378055
• Product Code: JWH
• UDI-Device Identifier: 10603295042372
• UDI-Public: 10603295042372
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1506-00-003
• Device Catalogue Number: 150600003
• Device Lot Number: 8407113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 04/29/2023; 06/19/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/01/2023; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2016
• 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 4 6MM.; UNK CEMENT SMARTSET GMV.; UNK CEMENT SMARTSET GMV.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female