BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S

    MDR report key: 8797318 · Received July 17, 2019

    Report

    Report Number
    3005180920-2019-00582
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    June 19, 2019
    Report Date
    July 17, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809156
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16.JULY.2019: LOT 177246: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-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 DEVICES INVOLVED IN THE COMPLAINT BATCH REVIEWS PERFORMED ON 16.JULY.2019: LINER: MPACT 01.32.3241 HCT FLAT PE HC LINER Ø32/D (K103721) LOT 177246: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-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. CUP: MPACT 01.32.150DH ACETABULAR SHELL Ø50 TWO-HOLES (K132879) LOT 177291: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-MAR-2018. EXPIRATION DATE: 2023-02-22. 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. STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0 (K093944) LOT 153415: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-NOV-2015. EXPIRATION DATE: 2020-10-31. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, THE PATHOGEN THAT MADE THE INFECTION RISE IS STILL UNKNOWN. ABOUT 1 YEAR AFTER SURGERY THE SURGEON EXPLANTED THE HIP IMPLANTS (STEM, BALL HEAD, CUP AND LINER), PERFORMED A WASHOUT AND IMPLANTED AN ANTIBIOTIC SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594414 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 176362 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention