BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE

    MDR report key: 13548449 · Received February 17, 2022

    Report

    Report Number
    3005180920-2022-00110
    Event Type
    Injury
    Date Received
    February 17, 2022
    Date of Event
    January 18, 2022
    Report Date
    April 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810800
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 JANUARY 2022. LOT 185415: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2018. EXPIRATION DATE: 2023-SEP-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: LATE INFECTION IN CEMENTED THA, 3 YEARS 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 ON 21 JANUARY 2022: LINER: MPACT 01.32.3644 HCT FLAT PE HC LINER Ø36/E (K103721) LOT. 188901, LOT 188901: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2018. EXPIRATION DATE: 2023-NOV-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. MECTAPLUG 01.33.102 MECTAPLUG PE SIZE 2 LOT. 188261 (ITEM NOT REGISTERED IN USA). LOT 188261: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2018. EXPIRATION DATE: 2023-DEC-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. STEM: QUADRA-C 01.12.043 CEMENTED, MIRROR POLISHING STD STEM SIZE 3 12/14 (K083558) LOT. 184785 LOT 184785: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2018. EXPIRATION DATE: 2023-SEP-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 Ø 36 SIZE M 0 (K080885) LOT. 182513. LOT 182513: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2018. EXPIRATION DATE: 2023-JUN-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    ON 8 APRIL 2022 WE NOTICED THAT THERE WAS AN ERROR ON THE BATCH REVIEW OF THE LINER: IMPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT. 188901. CORRECTED BATCH REVIEW: BATCH REVIEW PERFORMED ON 21 JANUARY 2022. LOT 188901: 110 ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2018. EXPIRATION DATE: 2023-NOV-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 109 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH TWO SIMILAR REPORTED EVENTS.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED 2 YEARS AND 8 MONTHS DUE TO INFECTION. ALL IMPLANTS REMOVED AND SPACER IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998018 CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE HIP ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.152MH 185415 07630030810800

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention