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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).No surgical confirmation has been provided that there was tibial tray loosening.

Event Description

Surgeon confirmed he had a patient with a primary attune fb cr knee, right side, implanted 2017 in a relatively young, active farmer, who presented with pain in nov 2020.Subsequent x-rays and ct scan have suggested tibial lysis and loosening, femur looks ok.Inflammatory markers are normal.Revision occurred on (b)(6) 2021.Surgeon explanted attune crfb size 8, 8mm insert and attune fb cemented tray.The femur was retained, and no patella component has ever been used in this patient.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : update 30-mar-2021: the investigation was re-opened upon receipt of the device.Examination of the returned device found no evidence of product malfunction or product error and the need for corrective action was not indicated.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• 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
• MDR Report Key: 11473297
• MDR Text Key: 239415747
• Report Number: 1818910-2021-04991
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042426
• UDI-Public: 10603295042426
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1506-00-008
• Device Catalogue Number: 150600008
• Device Lot Number: 8175621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FB INSRT SZ 8 8MM; ATTUNE FB TIB BASE SZ 8 CEM; UNK KNEE FEMORAL ATTUNE CR; ATTUNE CR FB INSRT SZ 8 8MM; ATTUNE FB TIB BASE SZ 8 CEM; UNK KNEE FEMORAL ATTUNE CR
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR