MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 9 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number	1506-00-009
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Clinical notification received for right knee revision to address migration and aseptic loosening of the tibial baseplate.Date of implantation: (b)(6) 2017.Date of revision: (b)(6) 2021; (right knee).Treatment: revision of tibial baseplate and insert.
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 from (b)(6) 2021, report that patient had a revision of tibial component right knee to address mechanical loosening of internal right knee prosthetic joint.Depuy components were used during this procedure along with competitor cement.The indicators for surgery included pain.The femoral and patella components were noted to be well fixed.
Additional 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 9 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12061319
• Report Number: 1818910-2021-13528
• Device Sequence Number: 3959444
• Product Code: OIY
• UDI-Device Identifier: 10603295042433
• UDI-Public: 10603295042433
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2021

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: 1506-00-009
• Device Catalogue Number: 150600009
• Device Lot Number: 8451723
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 06/21/2021; 08/09/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/05/2021; 08/10/2021
• 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 CR FB INSRT SZ 9 7MM; ATTUNE CR FEM RT SZ 9 CEM; ATTUNE FB TIB BASE SZ 9 CEM; ATTUNE MEDIAL DOME PAT 41MM; COMPETITOR BONE CEMENT (STRYKER); COMPETITOR BONE CEMENT (STRYKER); ATTUNE CR FB INSRT SZ 9 7MM; ATTUNE CR FEM RT SZ 9 CEM; ATTUNE FB TIB BASE SZ 9 CEM; ATTUNE MEDIAL DOME PAT 41MM; COMPETITOR BONE CEMENT (STRYKER); COMPETITOR BONE CEMENT (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 142