MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number	150600006
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced pain and inflammation.Patient underwent an attune tibial tray and insert revision due to loosening.
Additional Manufacturer Narrative
Product complaint # (b)(4).H10 additional narrative: us-fda mdr reportability determination: tibial tray and tibial insert were revised to address pain, inflammation, and tibial tray implant loosening at an unknown interface.It is reasonable to directly attribute pain and inflammation to the loose tibial tray implant.It is also fair to conclude that the tray caused/contributed to the event, given that the implant interface is a function of product design--none of the other known depuy products play a role in this.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary =attune tibial tray revision due to loosening.The product was not returned to depuy synthes, however photos were provided for review.The photo and x-ray investigation confirmed the reported allegation.The fixation surface of the implant was devoid of cement as well as there was evident burnishing consistent with micromotion of the device between the cement/implant interface.The overall appearance of the device exhibited scratches and other marks consistent with extraction damage.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed.As the observed condition of the [attune fb tib base sz 6 cem] would contribute to the complained device issue.  based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE FB TIB BASE SZ 6 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• 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: 17822462
• Report Number: 1818910-2023-19510
• Device Sequence Number: 12293460
• Product Code: JWH
• UDI-Device Identifier: 10603295042402
• UDI-Public: 10603295042402
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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 Catalogue Number: 150600006
• Device Lot Number: 8595830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2017
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE PS FB INSRT SZ 6 7MM.; ATTUNE PS FEM LT SZ 6 CEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 MO
• Patient Sex: Male