BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-C CEMENTED, MIRROR POLISHED STD STEM SIZE 1, SHORT NECK

    MDR report key: 11185283 · Received January 18, 2021

    Report

    Report Number
    3005180920-2021-00052
    Event Type
    Injury
    Date Received
    January 18, 2021
    Date of Event
    December 21, 2020
    Report Date
    January 18, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030802799
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 JANUARY 2021: LOT 2007204: 20 ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2020. EXPIRATION DATE: 2025-10-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 4 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: EARLY INFECTION IN HYBRID THA, FEW WEEKS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED BY ON 18 JANUARY 2021. THESE ITEMS WERE REVISED ON 23-DEC-2020 LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT. 2003330 LOT 2003330: 176 ITEMS MANUFACTURED AND RELEASED ON 3-JUL-2020. EXPIRATION DATE: 2025-06-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 103 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BALL HEADS: COCR 01.25.022 COCR BALL HEAD 12/14 Ø 32 SIZE M 0 (K072857) LOT. 188825 LOT 188825: 100 ITEMS MANUFACTURED AND RELEASED ON 6-MAR-2019. EXPIRATION DATE: 2024-02-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 96 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED BY ON 12 JANUARY 2021: BALL HEADS: COCR 01.25.022 COCR BALL HEAD 12/14 Ø 32 SIZE M 0 (K072857) LOT. 1905319 LOT 1905319: 110 ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2019. EXPIRATION DATE: 2024-11-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 100 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT. 182609 LOT 182609:110 ITEMS MANUFACTURED AND RELEASED ON 2-JUL-2018. EXPIRATION DATE: 2023-06-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 99 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CUP: MPACT 01.32.150DH ACETABULAR SHELL Ø50 TWO-HOLES (K1328799) LOT. 2003357 LOT 2003357: 130 ITEMS MANUFACTURED AND RELEASED ON 27-JUL-2020. EXPIRATION DATE: 2025-07-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 84 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTAPLUG 01.33.101 MECTAPLUG PE SIZE 1 LOT. 2003075 (ITEM NOT REGISTERED IN USA) LOT 2003075: 410 ITEMS MANUFACTURED AND RELEASED ON 22-JUL-2020. EXPIRATION DATE: 2025-07-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 282 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2020, ONE MONTH AFTER THE PRIMARY SURGERY A WASHOUT WAS PERFORMED, ON (B)(6)2020, THE SURGEON PERFORMED AGAIN A WASHOUT AND REVISED THE LINER AND HEAD DUE TO INFECTION. BLOOD CULTURE STILL POSITIVE FOR E COLI. THE SURGEON FINALLY REVISED ALL IMPLANTS ON (B)(6) 2021 VIA POSTERIOR APPROACH AND IMPLANTED COMPETITOR IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81959 STEM: QUADRA-C CEMENTED, MIRROR POLISHED STD STEM SIZE 1, SHORT NECK CEMENTED STEM LZO MEDACTA INTERNATIONAL SA 01.12.41SN 2007204 07630030802799

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention