BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE 52

    MDR report key: 10137535 · Received June 10, 2020

    Report

    Report Number
    3005180920-2020-00315
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    May 26, 2020
    Report Date
    June 10, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807893
    PMA / PMN Number
    K122911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 MAY 2020 LOT 184697: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2018. EXPIRATION DATE: 2023-09-13. 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. OHER DEVICES INVOLVED IN THE EVENT BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE M 0 LOT. 187071 (K112115) BATCH REVIEW PERFORMED ON 28 MAY 2020: LOT 187071: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2018. EXPIRATION DATE: 2023-11-21. 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. STEM: AMISTEM-H PROX. COAT. 01.18.172 AMISTEM-H PROXIMAL COATING STD STEM #2 LOT. 170857 (K161635). BATCH REVIEW PERFORMED ON 28 MAY 2020: LOT 170857: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-APR-2017. EXPIRATION DATE: 2022-04-06. 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. LINER: CC E CC LIGHT 01.26.2844HCT FLAT PE HC LINER 28 / E LOT. 181142 (K103352). BATCH REVIEW PERFORMED ON 28 MAY 2020: LOT 181142: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAY-2018. EXPIRATION DATE: 2023-05-14. 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. CLINICAL EVALUATION: 1 YEAR AFTER PRIMARY CEMENTLESS THA THE CUP IS FOUND TO BE LOOSE AND REQUIRES REVISION. AT SURGERY, ACCORDING TO REPORT, THE PRESENCE OF INFECTION HAS BEEN VERIFIED, AND THEREFORE WE SHOULD ASCRIBE THE CAUSE FOR LOOSENING TO THE INTERVENED INFECTION.

    Description of Event or Problem · 1

    LOOSE CUP HAS BEEN IDENTIFIED THROUGH A SPECT CT, WHERE THE AREA AT THE CUP WAS BRIGHT. REVISION CONFIRMED LOOSENESS. INFECTION HAS BEEN DETECTED INTRAOPERATIVELY (UNKNOWN PATHOGEN), ALTHOUGH PUNCTATION A WEEK EARLIER SHOWED NO INFECTION. SURGEON PROCEEDED EXPLANTING ALL COMPONENTS LEABING GIRDLESTONE HIP TEMPORARILY.1 YEAR AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604574 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE 52 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 01.26.45.1152 07630030807893

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention