MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATUN TIB AUG LM/RL SZ 3/4 10MM; KNEE TIBIAL TRAY ACCESSORY

Catalog Number	152303102
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	02/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).
Event or Problem Description
Patient reported with painful and unstable right tka from an outside hospital with no available operative report.Xrays indicated a subsided and loose tibial component with a stem extension appearing to have exited the lateral tibial cortex.The surgical plan was to retain the well-fixed femoral component and revise only the tibial component and insert.Upon explanting the tibial component construct it became evident that the component was preoperatively misidentified by the surgical team as an mbt revision tibia and was actually an attune revision component.No instruments or implants were immediately available for the attune system.The attending surgeon, while being advised of the off-label nature of his decision, decided it was in the best interests of the patient to implant a sigma mbt revision rp 15mm buildup tray and to modify and utilize a sigma tc3 rp revision insert to articulate with the size 3 attune revision femoral component which resulted in a stable overall construct.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination, but based on the returned x-rays and photographs the reported loosening and migration could be confirmed.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATUN TIB AUG LM/RL SZ 3/4 10MM
• Common Device Name: KNEE TIBIAL TRAY ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8420560
• Report Number: 1818910-2019-87277
• Device Sequence Number: 2051722
• Product Code: JWH
• UDI-Device Identifier: 10603295057550
• UDI-Public: 10603295057550
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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: 152303102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR