MAUDE Adverse Event Report: ENCORE MEDICAL L.P. STAR; SLIDING CORE,UHMPWE,10MM

Catalog Number	400-144F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - poly swap, unknown reason.
Additional Manufacturer Narrative
On (b)(6) 2024, in regard to a star total ankle poly swap case the agent reported that "the poly was in good shape actually he just had to go into the ankle and clean things up so he decided to just go ahead and swap the poly out since it had been 9 years since she had it done." there were 50 similar complaints identified in the timeframe reviewed for star poly swaps with no indication of poly breakage.Simulated use not conducted for either returned device(s) nor with similar parts.The poly was implanted for approximately 9 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 658 tibial polymer components (pn:400-14x) were sold between july 2023 and july 2024.With 51 reported events of star poly swaps, the occurrence rate is (b)(6).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 50 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 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.Per the reporter, "the poly was in good shape actually (the doctor) just had to go into the ankle and clean things up so (the doctor) decided to just go ahead and swap the poly out since it had been 9 years since (the patient) had it done." as there was no indication of poly failure and the poly was reported to be in "good shape", the root cause shall be attributed to surgeon preference.

• Brand Name: STAR
• Common Device Name: SLIDING CORE,UHMPWE,10MM
• 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: 24933083
• Report Number: 1644408-2026-00858
• Device Sequence Number: 20172595
• Product Code: NTG
• UDI-Device Identifier: 00886385026961
• UDI-Public: 00886385026961
• 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: 400-144F
• Device Lot Number: UNKNOW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2026
• 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
• Patient Sex: Unknown