BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT 01.32.3239HCT FLAT PE HC LINER Ø32/C

    MDR report key: 8357674 · Received February 21, 2019

    Report

    Report Number
    3005180920-2019-00074
    Event Type
    Injury
    Date Received
    February 21, 2019
    Date of Event
    January 23, 2019
    Report Date
    February 21, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811845
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 FEBRUARY 2019: LOT 177245: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-FEB-2018. EXPIRATION DATE: 2023-02-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT . ADDITIONAL IMPLANTS INVOLVED: CUP: MPACT 01.32.148DH ACETABULAR SHELL Ø48 TWO-HOLES(K132879) , LOT 178414: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-APR-2018. EXPIRATION DATE: 2023-03-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT . BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115), LOT 177694: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAR-2018. EXPIRATION DATE: 2023-03-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT . STEM: AMISTEM H 01.18.130 HA COATED STD STEM #0 (K093944), LOT 131626A: (B)(4) ITEM MANUFACTURED AND RELEASED ON 18-FEB-2018 (RESTERILIZATION OF THE ORIGINAL BATCH 131626). EXPIRATION DATE: 2023-01-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM.

    Description of Event or Problem · 1

    ON (B)(6) 2019 WE WERE INFORMED ABOUT A PATIENT WHO CAME IN DUE TO INFECTION. ON THE FOLLOWING DAY A REVISION SURGERY WAS PERFORMED 1 YEAR AFTER PRIMARY SURGERY. THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED THE STEM, HEAD, LINER AND CUP AND IMPLANTED ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151674 LINER: MPACT 01.32.3239HCT FLAT PE HC LINER Ø32/C HIP HC ACETABULAR LINER LPH MEDACTA INTERNATIONAL SA 177245 07630030811845

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention