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); Swelling (2091); No Code Available (3191)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).No device associated with this report was received for examination, however review of the provided photographs revealed evidence of polywear.No evidence was found of product error as a contributing factor to the abrasive wear noted in the photographs and the need for corrective action is not indicated at this time.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.Initial reporter occupation: lawyer.(b)(4).Investigation summary: no device associated with this report was received for examination, however review of the provided photographs revealed evidence of polywear.No evidence was found of product error as a contributing factor to the abrasive wear noted in the photographs and the need for corrective action is not indicated at this time.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.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
Received medical records on 06/06/2018.Medical records reviewed for mdr reportability.Left attune total knee revised to address pain, swelling, and aseptic loosening of the tibial base plate, at the cement to implant interface.An incidental unknown acl screw was explanted along with the tibial base plate and the tibial insert.The femur and patella components were retained.Depuy cement was used in primary.Doi: (b)(6) 2015; dor: (b)(6) 2017; (left knee).

• 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: 9848307
• Report Number: 1818910-2020-08448
• Device Sequence Number: 727357
• Product Code: JWH
• UDI-Device Identifier: 10603295046035
• UDI-Public: 10603295046035
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 1516-20-808
• Device Catalogue Number: 151620808
• Device Lot Number: 542504
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR