BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIPOLAR BIPOLAR CUP

    MDR report key: 19643569 · Received July 1, 2024

    Report

    Report Number
    0002648920-2024-00210
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 5, 2024
    Report Date
    October 1, 2024
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    KWY
    UDI-DI
    00889024115484
    PMA / PMN Number
    K833991
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 00500105028, LOT# 65823703, LINER 28 MM I.D. FOR USE WITH 50/51/52 MM O.D. SHELLS. CAT# 802202802, LOT# 3151441, FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +0 MM NECK LENGTH. G2: FOREIGN ¿ AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTED HEAD, BIPOLAR LINER AND SHELL COVERED IN BIO-DEBRIS. THE CONSTRUCT IS STILL ASSEMBLED WHICH INDICATES THE DISLOCATION OCCURRED BETWEEN THE SHELL AND NATURAL ACETABULUM. NO FURTHER EVALUATION CAN BE MADE. PICTURES WERE NOT PROVIDED OF THE STEM. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEW IDENTIFIED THE FOLLOWING: POSSIBLE MALPOSITION OF THE ACETABULAR CUP LINER ON THE INITIAL IMAGE WITH HORIZONTAL ORIENTATION. OF NOTE, THERE IS PARTIAL WITHDRAWAL OF THE FEMORAL COMPONENT FROM THE BONE ON THE SECOND IMAGE. DISLOCATION OF BOTH THE FEMORAL HEAD AND CUP LINER SUPERIORLY AND LIKELY POSTERIORLY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT WAS REPORTED THE PATIENT FELL, HOWEVER, THE REASON FOR THE FALL IS UNKNOWN. IT IS UNKNOWN IF THE STEM WITHDRAWING FROM THE BONE IS A RESULT OF THE DISLOCATION OR A CONTRIBUTING FACTOR OF THE DISLOCATION. THIS COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED MMI REPORT. 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 APPROXIMATELY TWO DAYS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION FOLLOWING A FALL DUE TO DISLOCATION. THE SHELL DISLOCATED FROM THE ACETABULUM. THE SHELL, LINER, AND HEAD WERE REVISED TO INCREASE STABILITY WITH A CONSTRAINED CUP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255443 MULTIPOLAR BIPOLAR CUP PROSTHESIS, HIP KWY ZIMMER MANUFACTURING B.V. N/A 66068310 00889024115484

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11 NARRATIVE