BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P COLLARED STD STEM SIZE 8

    MDR report key: 15400680 · Received September 12, 2022

    Report

    Report Number
    3005180920-2022-00696
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    August 17, 2022
    Report Date
    May 4, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720274
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24-AUG-2022: LOT 1904653: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 2024-09-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 24-AUG-2022: LINER: MPACT 01.32.3652HCT FLAT PE HC LINER Ø36/G (K103721) LOT 1900223: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-APR-2019. EXPIRATION DATE: 2024-04-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE HEAD AND LINER. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED HEAD, SLEEVE, LINER, CUP AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT PRIMARY SURGERY DATE IS (B)(6) 2019. THESE ARE THE REVISED PRODUCT: BATCH REVIEW PERFORMED ON 03-MAY-2023: LOT 1900091: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2019. EXPIRATION DATE: 2024-04-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 03-MAY-2023: LINER: IMPACT 01.32.4052HC10A FACE-CHANGING 10° PE HC LINER Ø40/G (K183582) LOT 1810856: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-APR-2019. EXPIRATION DATE: 2024-03-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.233H HEAD BIOLOX OPTION Ø 40 (K131518) LOT 2115395: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-FEB-2022. EXPIRATION DATE: 2027-01-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.162DH ACETABULAR SHELL Ø62 TWO-HOLES (K132879) LOT 178265: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAR-2018. EXPIRATION DATE: 2023-03-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.242A SLEEVE SIZE L (K131518) LOT 22C0012: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAR-2022. EXPIRATION DATE: 2027-02-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE HEAD AND LINER. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED HEAD, SLEEVE, LINER, CUP AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805950 AMISTEM-P COLLARED STD STEM SIZE 8 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.29.210 1900091 07630040720274

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention