MAUDE Adverse Event Report: ENCORE MEDICAL L.P. STAR; 8MM E+ SLIDING CORE STAR TOTAL ANKLE

Catalog Number	602-03-008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - unknown reason.
Additional Manufacturer Narrative
See d6 and h11.The new polyethylene component is pn 602-03-008, star e+ sliding core implant, 8mm, but the pn of the explanted component remains unknown.Due to the limited information available, the part and lot number could not be narrowed down and dhr review could not be completed.There were 51 star revision complaints identified in the timeframe reviewed.Similar complaints did not aid in root cause determination as there is very limited information available.No information was provided related to the surgical technique, so adherence to the ifu is unknown.Simulated use not conducted for either returned device(s) nor with similar parts.The construct had been implanted for an unknown amount of time, so simulated use testing would not be able to accurately recreate the physiological changes that occurred during implantation.No information was provided regarding the cause of the revision surgery and the original surgery date.For this reason, the similar complaints could not aid in the investigation.It is unknown if the doctor followed the surgical technique during both the original and revision surgeries, so simulated use testing could not occur.The explanted poly was not returned to the houston site, so visual and dimensional inspection did not occur.The root cause shall therefore remain unknown.

• Brand Name: STAR
• Common Device Name: 8MM E+ SLIDING CORE STAR TOTAL ANKLE
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 20701570
• Report Number: 1644408-2024-01870
• Device Sequence Number: 3851151
• Product Code: NTG
• UDI-Device Identifier: 00810028393493
• UDI-Public: 810028393493
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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 Catalogue Number: 602-03-008
• Device Lot Number: 2319461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 11/16/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown