BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø48 TWO-HOLES

    MDR report key: 10009077 · Received April 29, 2020

    Report

    Report Number
    3005180920-2020-00267
    Event Type
    Injury
    Date Received
    April 29, 2020
    Date of Event
    April 6, 2020
    Report Date
    April 29, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810732
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 APRIL 2020: LOT 188865: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2019. EXPIRATION DATE: 2024-02-13. 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. OTHER DEVICES INVOLVED IN THE EVENT: LINER: MPACT 01.32.3239HCT FLAT PE HC LINER Ø32/C LOT. 179359 (K103721). BATCH REVIEW PERFORMED ON 07 APRIL 2020: LOT 179359: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2018. EXPIRATION DATE: 2023-04-04. 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. STEM: AMISTEM COLLARED 01.18.230 STEM COLLARED HA COATED STD STEM #0 LOT. 176018 (K121011). BATCH REVIEW PERFORMED ON 07 APRIL 2020: LOT 176018: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JAN-2018. EXPIRATION DATE: 2023-01-21. 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 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 (K112115). BATCH REVIEW PERFORMED ON 07 APRIL 2020: LOT 189638: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-FEB-2019. EXPIRATION DATE: 2024-02-05. 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 AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER ALMOST 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473575 CUP: MPACT ACETABULAR SHELL Ø48 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.148DH 188865 07630030810732

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention