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 Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	02/21/2019
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
Patient received a right attune total knee to treat osteoarthritis.The patella was resurfaced and competitor cement x 2 was utilized.There were no indicated intra-operative complications.Patient received a right knee revision to address pain, instability, difficulty walking, and tibial tray loosening at the cement to implant interface.The surgeon noted a large amount of scar tissue, some of which was gray.The patellar and femoral components were well-fixed and retained.The tibial tray and tibial insert were revised with depuy products and depuy cement x 2.There were no indicated intra-operative complications.Doi: (b)(6) 2016.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.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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.Initial reporter occupation is lawyer.

• 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: 11604092
• Report Number: 1818910-2021-06850
• Device Sequence Number: 4352231
• Product Code: NJL
• UDI-Device Identifier: 10603295042433
• UDI-Public: 10603295042433
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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 Expiration Date: 06/30/2025
• Device Model Number: 1506-00-009
• Device Catalogue Number: 150600009
• Device Lot Number: 8148758
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 04/28/2021
• 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 FB TIB BASE SZ 9 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 9 6MM; ATTUNE PS FEM RT SZ 9 CEM; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT; ATTUNE FB TIB BASE SZ 9 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 9 6MM; ATTUNE PS FEM RT SZ 9 CEM; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR