BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOXDELTA CERAMIC TAPER LINER,SIZE II/36 - 52 MM O.D. SIZE II SHELL

    MDR report key: 18229103 · Received November 29, 2023

    Report

    Report Number
    0009613350-2023-00647
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    October 30, 2023
    Report Date
    February 9, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, ø 36/+7, TAPER 12/14, #ITEM00877503604, LOT#3041341. G2. REPORT SOURCE: CHINA. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE BIOLOX HEAD, THE BIOLOX LINER AS WELL AS 29 SMALL CERAMIC FRAGMENTS HAVE BEEN RECEIVED FOR EXAMINATION. THE HEAD SHOWS A LARGE AREA OF METALLIC MARKS CONCENTRATED ON ONE HALF OF THE HEAD. ON THE OTHER HALF OF THE HEAD, POINT AND LINE-SHAPED METAL MARKS CAN BE SEEN. THE HEAD TAPER SHOWS A REGULAR SEATING PATTERN FROM THE CONNECTION TO THE STEM TAPER. THE EDGE OF THE LINER IS COMPLETELY BROKEN OUT AND SHOWS AN IRREGULAR PATTERN. A TOTAL OF 29 PIECES OF DIFFERENT SIZES HAVE BROKEN OUT OF THE RIM. THE FRACTURE SURFACES OF THE LINER AND THE FRACTURE FRAGMENTS APPEAR SMOOTH WITH METAL MARKS. METAL MARKS CAN BE FOUND ON THE ARTICULATION SURFACE AND ALSO ON THE OUTER SURFACE WHICH CONNECTS TO THE CUP. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICE IS USED FOR TREATMENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. HOWEVER, AS THE ACETABULAR SHELL AND THE STEM ARE UNKNOWN, A REVIEW OF THE ENTIRE SYSTEM COULD NOT BE PERFORMED. THE REVIEW OF MEDICAL RECORDS IDENTIFIED THAT THE PATIENT HAD AN INITIAL LEFT HIP ARTHROPLASTY PERFORMED ON (B)(6) 2023. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023 DUE TO FRACTURE OF THE CERAMIC LINER. THREE RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW OF 2 UNDATED AP AND 1 UNDATED OBLIQUE VIEW OF THE LEFT HIP IDENTIFIED A LEFT HIP ARTHROPLASTY AND RADIOPAQUE DEBRIS ABOUT THE PROSTHETIC JOINT SPACE CONSISTENT WITH A FRACTURED CERAMIC LINER. THERE IS NO DISLOCATION, OSSEOUS FRACTURE OR LOOSENING. THE FEMORAL STEM IS LATERALLY POSITIONED IN RELATION TO THE CENTRAL MEDULLARY CANAL OF THE FEMUR. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. NO CORRECTIVE, PREVENTIVE OR FIELD ACTION WAS TAKEN FOLLOWING THE INVESTIGATION OF THIS EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON (B)(6) 2023. APPROXIMATELY A MONTH AND A HALF POST-IMPLANTATION, A REVIEW OF THE X-RAYS AT THE HOSPITAL REVEALED SCATTERED VISUALIZATION OF THE HIP. THIS WAS FOLLOWED BY ANOTHER REVIEW OF THE X-RAYS (APPROXIMATELY TWO MONTHS POST-IMPLANTATION), WHICH REVEALED AN INCREASE IN THE SCATTERED VISUALIZATION AND DISPLACEMENT OF THE HIP. THE PATIENT WAS RETURNED TO THE ORIGINAL SURGICAL HOSPITAL ON (B)(6) WHERE IT WAS DETERMINED THAT THE CERAMIC LINER WAS FRACTURED AND A REVISION SURGERY WAS PERFORMED ON (B)(6), IN WHICH THE CERAMIC LINER AND CERAMIC HEAD WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INITIAL LEFT HIP ARTHROPLASTY PERFORMED ON (B)(6) 2023. SUBSEQUENTLY, APPROXIMATELY 3 MOTHS LATER THE PATIENT WAS REVISED DUE TO FRACTURED CERAMIC LINER. NO FURTHER DETAILS OR OUTCOMES HAVE BEEN PROVIDED. DILIGENCE IS COMPLETED AND TO DATE NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888088 BIOLOXDELTA CERAMIC TAPER LINER,SIZE II/36 - 52 MM O.D. SIZE II SHELL PROSTHESIS, HIP KWA ZIMMER GMBH N/A 3128072

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention| H SEE H10.