BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    MDR report key: 8612051 · Received May 15, 2019

    Report

    Report Number
    3005180920-2019-00385
    Event Type
    Injury
    Date Received
    May 15, 2019
    Date of Event
    April 18, 2019
    Report Date
    May 15, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810824
    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 MAY 2019: LOT 181635: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUN-2018. EXPIRATION DATE: 2023-06-11. 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 IMPLANTS INVOLVED: LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721), LOT 182615: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JUL-2018. EXPIRATION DATE: 2023-07-15. 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. SCREWS: MPACT 01.32.6520 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 20 (K103721) LOT 184330: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2018. EXPIRATION DATE: 2023-07-04. 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 STEM: QUADRA-H 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3 (K082792), LOT 181753: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUN-2018. EXPIRATION DATE: 2023-06-12. 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. BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115), LOT 176837: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-FEB-2018. EXPIRATION DATE: 2023-02-08. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: INFECTION IN CEMENTLESS THA, 5 MONTHS 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. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: THE IMAGES SHOW THE IMPLANT JUST EXPLANTED FROM THE PATIENT; FROM THE RECEIVED PHOTOS NO ANOMALIES SEEM TO BE PRESENT ON THE CUP. THE REASON REMAINS UNKNOWN BUT THERE ARE NO ANY PARTICULAR SIGNS TO CORRELATE THE EVENT TO AN IMPLANT DEFECT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO INFECTION 5 MONTHS AFTER PRIMARY. PATIENT HAD A REOCCURRING INFECTION, HE HAD 3 WASHOUTS PRIOR WITH NO EFFECT. ASPIRATION 4 MONTHS AFTER PRIMARY SHOWED INFECTION. THE PATHOGEN IS STAPH EPIDERMIDIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406284 CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 181635 07630030810824

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention