BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P

    MDR report key: 20683185 · Received November 14, 2024

    Report

    Report Number
    3005180920-2024-00946
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    October 15, 2024
    Report Date
    November 14, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040719988
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 OCTOBER 2024 25 ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2020. EXPIRATION DATE: 2025-10-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 22 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT: A REVISION SURGERY WAS PERFORMED TWO YEARS AFTER A PRIMARY TOTAL HIP ARTHROPLASTY IMPLANTATION. THE PATIENT REPORTED EXPERIENCING PAIN AND A DISCREPANCY IN LEG LENGTH. PRE-REVISION SCINTIGRAPHY REVEALED PERIPROSTHETIC UPTAKE. DURING THE PRIMARY SURGERY, AN INTRAOPERATIVE FRACTURE OCCURRED, WHICH WAS MANAGED WITH BONE CERCLAGES. THE AVAILABLE PRE-REVISION X-RAY IMAGES SHOW A FULLY SUBSIDED STEM, RESULTING IN LEG SHORTENING. THE PROXIMAL FEMORAL SHAFT PROFILE APPEARS SLIGHTLY DEFORMED, LIKELY DUE TO THE PREVIOUS FRACTURE. THE OBSERVED SUBSIDENCE COULD BE ATTRIBUTED TO EITHER INSUFFICIENT INITIAL STEM STABILITY, GIVEN THE FRACTURE, OR POSSIBLE LOOSENING, AS SUGGESTED BY SCINTIGRAPHY FINDINGS. HOWEVER, SUBSIDENCE IS A KNOWN COMPLICATION THAT IS WELL-DOCUMENTED IN THE LITERATURE. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS DEFECTIVE OR MALFUNCTIONING. ADDITIONAL DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 11 NOVEMBER 2024 ON BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT. 2100259 310 ITEMS MANUFACTURED AND RELEASED ON 23-APR-2021. EXPIRATION DATE: 2026-04-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 293 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON (B)(6) 2024 ON LINER: MECTACER 01.29.402 CERAMIC LINER Ø 28 / B LOT. 2107517 DEVICES NOT REGISTERED IN USA LOT 2107517: 60 ITEMS MANUFACTURED AND RELEASED ON 29-SEP-2021. EXPIRATION DATE: 2026-09-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. AMISTEM P BROACH LOT. UNKNOWN IN THE PRIMARY SURGERY ON 15 NOVEMBER 2024, WHEN THE FEMORAL FRACTURE OCCURRED, AMISTEM P BROACH WAS USED. BOTH LOT AND REFERENCE ARE UNKNOWN. ROOT CAUSE: THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    DURING THE PRIMARY SURGERY PERFORMED ON (B)(6) 2022 THERE WAS A BONE FRACTURE, FIXED WITH CERCLAGES. THE BONE FRACTURE HAPPENED DURING HIP REDUCTION WITH TRIAL BROACH.ON (B)(6) 2023 THE PATIENT REPORTED HIP PAIN AND THE LEG WAS FOUND TO BE SHORTER. AT ABOUT 1 YEAR AND 11 MONTHS (ON 15 OCTOBER 2024) POST PRIMARY THE STEM, HEAD AND LINER REVISED SUCCESSFULLY. THE CUP WAS WELL FIXED TO THE BONE AND WAS NOT REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2187078 AMISTEM-P AMISTEM-P STD STEM SIZE 00 LPH MEDACTA INTERNATIONAL SA 01.18.399 2005831 07630040719988

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention