BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø56 MULTI-HOLE

    MDR report key: 8699597 · Received June 14, 2019

    Report

    Report Number
    3005180920-2019-00469
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 17, 2019
    Report Date
    June 14, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810862
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 MAY 2019: LOT 188890: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-FEB-2019. EXPIRATION DATE: 2024-02-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 2 OTHER ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES WERE INVOLVED IN THE EVENT CUP: MPACT 01.32.158MH ACETABULAR SHELL Ø58 MULTI-HOLE LOT. 156003 (K132879): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAR-2016. EXPIRATION DATE: 2021-02-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OTHER ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. LINER: MPACT 01.32.3248HCAT HOODED PE HC LINER Ø32/F LOT. 179368 (K132879): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAR-2018. EXPIRATION DATE: 2023-03-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OTHER ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. LINER: MPACT 01.32.3248HCT FLAT PE HC LINER Ø32/F LOT. 186967 (K103721): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2018. EXPIRATION DATE: 2023-10-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OTHER ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: SHELL AND LINER DO NOT SHOW ANY PARTICULAR SIGN ON THE OUTSIDE, WITH EXCEPTION OF LITTLE BONE MATTER ON THE OUTER SIDE OF THE SHELL. SHELL AND LINER ARE ASSEMBLED, AD A DISCREPANCY IN THE ASSEMBLY IS EVALUABLE BY MOVING THE LINER WITH RESPECT TO THE SHELL. MICROMOTION IS DETECTABLE. FULL DIMENSIONAL ANALYSIS OF BOT SHELL AND LINER HAS BEEN REQUESTED. AFTER DIMENSIONAL ANALYSIS: PE LINER SHOWS SEVERAL QUOTES OUT OF TOLERANCE RANGE. CONSIDERING THAT THE COMPONENT HAS BEEN STERILIZED, NO COMMENTS REGARDING THE LINER CAN BE SIGNIFICANT. THE SHELL SHOWS A DISCREPANCY OF 0.005MM WITH RESPECT TO UPPER TOLERANCE. THIS MIGHT BE DUE TO SEVERAL IMPACTION ATTEMPTS AND REMOVAL PROCEDURE. IT IS NOT POSSIBLE TO DETERMINE THE CAUSE THAT BROUGHT TO THE COMPLAINT.

    Description of Event or Problem · 1

    THE SURGEON WAS NOT ABLE TO FIX A 56MM MPACT CUP IN THE PATIENT'S ACETABULUM. HE PERFORMED AN ADDITIONAL REAMING AND REPLACED THE CUP WITH A NEW 58MM MPACT CUP, BUT HE WAS NOT ABLE TO FIX IT AGAIN, 5 MPACT SCREWS HAVE BEEN THEN USED. AFTER THAT, HE TRIED TO ENGAGE A FLAT LINER, BUT HE WAS NOT ABLE. HE REPLACED THE FLAT LINER WITH A NEW HOODED LINER BUT HE WAS NOT ABLE AGAIN. AFTER THE CONFIRMATION THAT THERE WERE NOT OBSTACLES BETWEEN CUP AND LINER, HE TRIED AGAIN TO ENGAGE THE FLAT LINER CHANGING THE DIRECTION OF THE IMPACTION AND APPLYING A STRONGER FORCE. THE FLAT LINER SEEMED TO BE NOT COMPLETELY ENGAGED, THE SURGEON CONFIRMED THE FLAT LINER DID NOT DISENGAGE BY HAND AND COMPLETED THE SURGERY. AFTER THE SURGERY, THE SURGEON TRIED TO ENGAGE THE 56MM MPACT CUP WITH THE HOODED LINER, OUTSIDE THE PATIENT, AND HE WAS ABLE TO COUPLE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493759 CUP: MPACT ACETABULAR SHELL Ø56 MULTI-HOLE HIP ACETABULAR SHELL MULTI-HOLE LPH MEDACTA INTERNATIONAL SA 188890 07630030810862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other