BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE S -3.5

    MDR report key: 16970519 · Received May 20, 2023

    Report

    Report Number
    3005180920-2023-00371
    Event Type
    Injury
    Date Received
    May 20, 2023
    Date of Event
    April 26, 2023
    Report Date
    July 26, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805202
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION OF DATA REPORTED: - DESPITE THE INITIAL COMMUNICATION, THE DEVICES WERE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02-MAY-2023. LOT 151916: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-SEP-2015. EXPIRATION DATE: 2020-07-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. STEM: AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4 (K093944) LOT. 155658: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-FEB-2016. EXPIRATION DATE: 2021-01-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICA AFFAIRS DEPARTMENT REVISION SURGERY 6 YEARS AND 11 MONTHS AFTER PRIMARY THA DUE TO OSTEOLYSIS POSSIBLY RELATED TO SUSPECTED TRUNNIONOSIS FROM THE COCR HEAD METAL TAPER IN THE PROXIMAL FEMUR AND AROUND THE CUP IMPLANT. HOWEVER, THE PICTURES THAT WERE EXAMINED DID NOT SHOW MACROSCOPIC DAMAGES TO THE HEAD THAT WOULD BE COMPATIBLE WITH SUCH DIFFUSE OSTEOLYSIS. FROM RADIOGRAPHIC IMAGES, A GREATER TROCHANTER FRACTURE IS VISIBLE, PROBABLY RELATED TO OSTEOLYTIC CONSEQUENSES. THE SURGEON REVISED SUCCESSFULLY CUP, HEAD AND LINER. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER FROM THE DESCRIPTION AND FROM THE PICTURES RECEIVED IT IS NOT POSSIBLE TO ESTABLISH A ROOT CAUSE. FROM THE PICTURES WE CAN SEE THAT THE COCR 01.25.030 COCR BALL HEAD 12/14 Ø 36 SIZE S -3.5 LOT. 151916 SEMS TO HAVE SOME SIGNS /SCRATCHES IN THE INNER PART OF THE CONICAL CONNECTION BUT THE IMAGES ARE NOT SUFFICIENT CLEAR. THE IMAGES NOT SHOW MACROSCOPIC DAMAGES TO THE HEAD THAT WOULD BE COMPATIBLE WITH SUCH DIFFUSE OSTEOLYSIS MENTIONED IN THE EVENT DESCRIPTION. IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE OF THESE SCRATCHES SINCE THEY COULD POTENTIALLY HAVE BEEN CAUSED BOTH FROM THE POSSIBLE WARE BETWEEN THE STEM TAPER AND THE FEMORAL HEAD CONNECTION AND DURING THE HEAD REMOVAL PHASE. WE WILL TRY TO BETTER UNDERSTAND FROM THE VISUAL INSPECTION ONCE THE SPECIMENS WILL BE AVAILABLE.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED AT ABOUT 6 YEARS AND 11 MONTHS AFTER PRIMARY DUE TO SUSPECTED TRUNNIONOSIS FROM THE COCR HEAD METAL TAPER AND OSTEOLYSIS IN THE PROXIMAL FEMUR AND AROUND THE CUP IMPLANT. MOREOVER, X-RAYS SHOW A GREATER TROCHANTER FRACTURE. THE SURGEON REVISED SUCCESSFULLY CUP, HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511276 BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE S -3.5 HIP METAL FEMORAL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.030 151916 07630030805202

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention