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

Catalog Number	400-142F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Poly swap, unknown reason.Due to the original star ankle construct lot numbers remaining unknown, simulated use testing cannot be conducted utilizing similar parts to simulate the event.Additionally, the construct was implanted for approximately 10 years, so simulated use testing would not be able to accurately recreate the physiological changes that occurred during implantation.There were no similar complaints identified for star total construct removals.Ohr review was not conducted due to the complaint part not being returned and the lot numbers remaining unknown.It is unknown if the doctor followed the surgical technique with the limited information available.The star construct was not returned, so visual and dimensional inspection did not occur.Simulated use testing did not occur as the poly was implanted for an approximately 10 years and the part and lot numbers remaining unknown.The reason for removal remains unknown.The reporter stated the star total ankle components were removed "because there were in the patient for 1 o years so dr.Bloome did a revision".Based on the limited information, and the parts not being returned, the root cause shall remain as unknown.The following information remains unknown: - patient height, weight, bone quality, activity level, noncompliance, and co-morbidities.- inventory type.- lot numbers.- nventory status.Information not provided is not available to the reporter.Thus, good faith effort was achieved.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 736 tibial polymer components (pn:400-14x) were sold during (b)(6) 2022 and (b)(6) 2023.With 1 reported events of total construct removal, the occurrence rate is 0.136%.Thus, an occurrence level of 5 (frequenl/high) is conservative and appropriate.Per rf-str-0001 revision 2 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.As the reason for removal and root cause remain unknown, no further action will be taken at this time.The field shall continue to be monitored through the complaint intake system.Though the root cause is unknown, it is not expected to be attributed to the supplier.
Event or Problem Description
Revision surgery - poly swap, unknown reason.

• 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 ; 5128346313
• MDR Report Key: 24678169
• Report Number: 1644408-2026-00617
• Device Sequence Number: 10149383
• Product Code: NTG
• UDI-Device Identifier: 00886385026947
• UDI-Public: 00886385026947
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 03/23/2026

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: 08/08/2023
• Initial Report FDA Received Date: 03/24/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 400-254 LOT: UNKNOWN.; 400-263 LOT: UNKNOWN.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female