BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL 62 TWO-HOLES

    MDR report key: 10640899 · Received October 7, 2020

    Report

    Report Number
    3005180920-2020-00689
    Event Type
    Injury
    Date Received
    October 7, 2020
    Date of Event
    August 19, 2020
    Report Date
    October 7, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810978
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 SEPTEMBER 2020: LOT 157832: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-APR-2016. EXPIRATION DATE: 2021-04-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED. BATCH REVIEW PERFORMED ON 14 SEPTEMBER 2020 STEM: AMISTEM COLLARED 01.18.238 STEM COLLARED HA COATED STD STEM SIZE 8 (K121011) LOT 172628: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-SEP-2017. EXPIRATION DATE: 2022-09-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 6 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: FEW DAYS AFTER PRIMARY CEMENTLESS THA DISLOCATION OCCURS. THE STEM IS POSITIONED IN VALGUS AND POSSIBLY UNDERSIZED. THE POSITION OF THE CUP APPEARS SUBOPTIMAL TOO, PARTICULARLY IN TERMS OF ANTEVERSION. THE EXTREMELY LOW QUALITY OF THE IMAGES SUPPLIED DOES NOT ALLOW A PROPER EVALUATION TO BE CARRIED OUT. VALGUS STEM AND SUBOPTIMAL CUP ANTEVERSION ARE HOWEVER LIKELY CAUSES FOR AN EARLY DISLOCATION. NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    THE PATIENT HIP HAS DISLOCATED (HEAD FROM LINER) TWICE SINCE THE PRIMARY SURGERY ON (B)(6) 2020, BOTH TIMES WHILST THE SURGEON WAS ON HOLIDAY. THE PATIENT NEEDED AN URGENT REVISION ONCE HE CONSULTED HIM ON HIS RETURN. THE STEM WAS REMOVED AND REPLACED WITH A COMPETITOR STEM. THE CUP WAS SALVAGED. THE CUP INTRODUCER WAS ENGAGED IN THE CUP AND THE ANTEVERSION MANUALLY DECREASED. NEW 20-DEGREE LINER IMPLANTED. PATIENT APPEARED MORE STABLE. DURING PRIMARY: VALGUS STEM PLACEMENT, ANTE VERSION ON BOTH STEM AND CUP AND INCORRECT CHOICE OF OFFSET STEM AND HEAD, CONTRIBUTED TO AN INADEQUATE HIP OFFSET AND SUCCESSIVE DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104789 MPACT ACETABULAR SHELL 62 TWO-HOLES HIP ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.162DH 157832 07630030810978

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention