MAUDE Adverse Event Report: ENCORE MEDICAL L.P. STAR; FA - PR-21-003 STAR E+ SLIDE CORE IMPLANT (DWG 302-03-000)

Catalog Number	602-03-007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/14/2025
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 - due to infection.
Additional Manufacturer Narrative
Limited information is available regarding the original surgery and the part number and lot number of the original implants.Therefore, dhr review cannot occur.This is the second complaint related to cyst formation in the rolling year.Previous complaint, (b)(4), had similarly limited information available and an unknown root cause.This investigation will be completed to create a record in the agile complaint system.Surgical technique review could not occur due to the limited information available regarding the original implantation.The explanted polyethylene component was discarded and the facility and could not be inspected.The tibial and talar components remain implanted in the patient, so cannot be inspected as well.(b)(4) star ankle risk matrix rev 3 was reviewed.23.2 implant failure that leads to unintended revision surgery with multifactorial reasons has a severity of 4 (significant) and a mitigated occurrence level of 3 (seldom/low), which corresponds to a risk index level of 2.Severity level of 4 (significant) is appropriate as there could be permanent impairment of body function if revision surgery does not occur.There were 694 star sliding cores (pns 99-0028-1x, 602-03-00x, 400-14x) sold between (b)(6) 2024 and (b)(6) 2025.Although only 2 revisions related to cyst formation have occurred in the rolling year, 35 star revisions related to identified issues occurred, leading to an occurrence rate of (b)(4).This would correspond to an occurrence level of 5 (frequent/high), which is for frequencies greater than (b)(4).The risk matrix does not adequately capture the occurrence level of risks associated with implant failure and shall be updated to better reflect this information.Per rf-str-0001 revision 3 risk benefit analysis for u23.2, "every endoprosthesis has a limited lifespan.With state-of-the-art techniques, there is no potential for further mitigation of the risks from a clinical point of view".Therefore, the risk has been mitigated as far as possible.There are many potential causes for cyst formation under total ankle implants.Because the lot numbers of the original implants, surgeon, surgical technique, and duration of implantation are unknown, the root cause will remain unknown.This is the second star complaint related to cyst formation in the rolling year.Star revision complaints that occurred in the rolling year have unknown root causes due to various durations of implantation and unknown physiological conditions that occurred between the original and revision surgeries.There is no trend that can be identified related to component size, surgical conditions, timeframes, etc.The residual risk acceptance in the risk matrix signifies that the benefits of joint replacement outweighs risks associated with component breakage.

• Brand Name: STAR
• Common Device Name: FA - PR-21-003 STAR E+ SLIDE CORE IMPLANT (DWG 302-03-000)
• 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: 21360795
• Report Number: 1644408-2025-00207
• Device Sequence Number: 8590444
• Product Code: NTG
• UDI-Device Identifier: 00810028393486
• UDI-Public: 00810028393486
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: 602-03-007
• Device Lot Number: 2314111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/22/2025
• 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: Other
• Patient Sex: Unknown