MAUDE Adverse Event Report: ENCORE MEDICAL L.P. STAR; SLIDING CORE, UHMPWE,6M (STERILE PACKAGED)

Catalog Number	400-140F
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Poly swap, pain the poly component was 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.There were 52 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 part and lot numbers remain unknown for the similar complaints.Ohr review was not conducted due to the part and lot number 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 "patient was experiencing considerable pain.In conjunction to the possible poly swap, dr.Humbyrd will be revising a subtalar fusion (x2) screws of unknown manufacturer." as the source of the pain can not be attributed to the poly, and no photographs or x-rays were provided, the root cause shall remain as unknown.The following information remains unknown: date implanted, patient height, weight, bone quality, activity level, noncompliance, and co-morbidities inventory type, part and lot numbers.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 is to be noted that no adverse events were reported resulting from the swapped poly.It was determined that 688 polymer components (pn:400-14x) were sold between february 2023 and february 2024.With 53 reported events, the occurrence rate is 7.70%.Thus, an occurrence level of 5 (frequenuhigh) 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.Though the root cause remains unknown, it is not expected to be attributed to the supplier.
Event or Problem Description
Revision surgery - poly swap.Pain.

• Brand Name: STAR
• Common Device Name: SLIDING CORE, UHMPWE,6M (STERILE PACKAGED)
• 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: 24761085
• Report Number: 1644408-2026-00694
• Device Sequence Number: 13078263
• Product Code: NTG
• UDI-Device Identifier: 00886385026923
• UDI-Public: 00886385026923
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/01/2026

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
• Device Catalogue Number: 400-140F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 04/01/2026
• 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 Age: 62 YR
• Patient Sex: Female