MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 4 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-00-224
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The patient underwent a right knee revision due to tibial tray and femoral component loosening at the cement to implant interface.Two depuy cement products were used during the primary operation.The patellar component was retained.Competitor products were implanted during the revision with competitor cement.There were no indicated intra-operative complications.Doi: (b)(6) 2017; dor: (b)(6) 2019; right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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 synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes 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.
Event or Problem Description
Medical records received.On (b)(6) 2019, the patient was revised to address aseptic loosening right total knee.Competitor components were used during this procedure.During the procedure the surgeon observed loosening of the tibial tray and femoral components at the cement/implant interface.The insert was noted to have no evidence of wear.The patella was noted to be stable and was not revised.

• Brand Name: ATTUNE CR FEM RT SZ 4 NAR CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10937392
• Report Number: 1818910-2020-26014
• Device Sequence Number: 790911
• Product Code: JWH
• UDI-Device Identifier: 10603295041276
• UDI-Public: 10603295041276
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1504-00-224
• Device Catalogue Number: 150400224
• Device Lot Number: 8428957
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 01/07/2021; 06/17/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/08/2021; 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE AOX PAT DOME 32MM; ATTUNE CR FB INSRT SZ 4 5MM; ATTUNE CR FEM RT SZ 4 NAR CEM; ATTUNE FB TIB BASE SZ 4 CEM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; ATTUNE AOX PAT DOME 32MM; ATTUNE CR FB INSRT SZ 4 5MM; ATTUNE CR FEM RT SZ 4 NAR CEM; ATTUNE FB TIB BASE SZ 4 CEM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR