MAUDE Adverse Event Report: ENCORE MEDICAL L.P. STAR; SLIDJNG CORE, UHMPWE,8MM

Catalog Number	400-142F
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Agent reported a revision star total ankle on (b)(6) 2024 on a patient that received their original surgery at some point in 2012.Doctor found the ankle had become unbalanced due to soft tissue loosening and potential poly wear.The old poly was removed and replaced with another 8mm core.There was slight oxidization on the poly but did not appear to be any significant wear.The old poly was unable to be obtained as the facility requires explants be discarded.No pictures were taken intraoperatively either due to poly being discarded." no significant adverse event was selected on the feedback form, but there was no additional harm noted to the patient.The product feedback form states "the old poly was removed and replaced with another 8mm core" and the case sheet states an 8mm sliding core (400-142f) was implanted during the revision, but the original case sheet was not provided.With the information available and provided by the reporter, the part and lot numbers for the original poly component were unable to be confirmed.Thus, dhr review did not occur.Limited information was provided for the surgical technique / conformance to the ifu.Simulated use not conducted for either returned device(s) nor with similar parts.The construct has been implanted for approximately 12 years, so simulated use testing would not be able to accurately recreate the physiological changes that occurred during implantation.The overall risk is high with a risk index of 3.Severity level of 4 (significant) is appropriate as there could be permanent functional impairment of body function and the failure may occur with or without warning.It was determined that 666 tibial polymer components (pn:400-14x) were sold between (b)(6) 2023 and (b)(6) 2024.With 56 reported events of star poly swaps, the occurrence rate is (b)(4).Thus, an occurrence level of 5 (frequent/high) is appropriate.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 shall remain appropriate.There were 55 similar complaints identified for star poly swaps with no indication of poly damage.Similar complaints identified do not aid in the investigation for this complaint as the lot numbers remain unknown for the similar complaints.Dhr review was not conducted due to the part and lot numbers remaining unknown.It is unknown if the doctor followed the surgical technique with the limited information available regarding the original implantation.The poly was not returned to the houston site, so visual and dimensional inspection did not occur.Simulated use testing did not occur.The reporter stated the "ankle had become unbalanced due to soft tissue loosening and potential poly wear.The old poly was removed and replaced with another 8mm core.There was slight oxidization on the poly but did not appear to be any significant wear".As the poly was not returned and no photos were provided, the "oxidation" could not be confirmed.Due to the limited information regarding the reason for removal, the root cause shall remain as unknown.
Event or Problem Description
Revision surgery - due to poly wear.

• Brand Name: STAR
• Common Device Name: SLIDJNG CORE, UHMPWE,8MM
• 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
• MDR Report Key: 24933086
• Report Number: 1644408-2026-00855
• Device Sequence Number: 17481965
• Product Code: NTG
• UDI-Device Identifier: 00886385026947
• UDI-Public: 00886385026947
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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: 400-142F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2024
• Initial Report FDA Received Date: 04/20/2026
• 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; Other
• Patient Age: 60 YR
• Patient Sex: Male