MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 8 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-808
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).No surgical confirmation has been provided that there was tibial tray loosening.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
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.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: (b)(6) 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.H10 additional narrative: added: d4 (lot), d9, h4 corrected: g1, h3.

• Brand Name: ATTUNE CR FB INSRT SZ 8 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11473294
• Report Number: 1818910-2021-04990
• Device Sequence Number: 3705609
• Product Code: JWH
• UDI-Device Identifier: 10603295046035
• UDI-Public: 10603295046035
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1516-20-808
• Device Catalogue Number: 151620808
• Device Lot Number: 447870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 03/29/2021; 03/31/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 03/30/2021; 04/01/2021
• 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 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR