MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 7 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151620705
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Adhesion(s) (1695); Foreign Body Reaction (1868); Synovitis (2094)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient received a left attune tka to treat severe arthritis.The patella was resurfaced and competitor cement x 1 was utilized.The procedure was completed without complications.Dor: (b)(6) 2023: patient received a left knee revision to treat suspected tibia tray loosening.Upon entering the joint, metallosis, synovitis, and scar tissue were debrided.The femoral component was well-fixed and aligned but revised to accommodate the revision construct.The explanted tibial insert showed signs of minimal wear and oxidation.The revised tibial tray was grossly loose and debonded at the cement to implant interface.The patella was well-fixed with signs of minimal wear but retained.The patient received a depuy attune revision construct.The procedure was completed without complications.Doi: (b)(6) 2014.Dor: (b)(6) 2023.Left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).E3 initial reporter occupation: lawyer 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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR FB INSRT SZ 7 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17540741
• Report Number: 1818910-2023-16672
• Device Sequence Number: 6496687
• Product Code: JWH
• UDI-Device Identifier: 10603295045885
• UDI-Public: 10603295045885
• 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: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2023

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: 01/31/2018
• Device Catalogue Number: 151620705
• Device Lot Number: 336482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CR FEM LT SZ 7 CEM.; ATTUNE FB TIB BASE SZ 6 CEM.; ATTUNE MEDIAL DOME PAT 38MM.; ZIMMER PALACOS BONE CEMENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male