BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELL WITH CLUSTER HOLES POROUS 54 MM O.D. SIZE JJ

    MDR report key: 8743850 · Received June 28, 2019

    Report

    Report Number
    0001822565-2019-02725
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    June 3, 2019
    Report Date
    September 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K091508
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PRIMARY OP NOTES WERE REVIEWED AND NO IDENTIFIED POSTERIOR APPROACH. STANDARD FEMORAL & ACETABULAR PREP. NEUTRAL POLY TRIALED BUT WAS UNSTABLE; CHANGED. NO COMPLICATIONS. REVISION OP NOTES WERE NOT PROVIDED FOR REVIEW. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED RIGHT ACETABULAR CUP APPEARS ABNORMALLY POSITIONED WITH AN ELEVATED ABDUCTION ANGLE (LATERAL INCLINATION) OF 58 DEGREES. THERE IS NO SUBLUXATION OR DISLOCATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ZIMMER LINER CAT#00885201136 LOT#63978781. ZIMMER HEAD CAT#00801803603 LOT#64020862. ZIMMER STEM CAT#0100351002 LOT#2945295. ZIMMER CENTRALIZER CAT#01.00358.010 LOT#2929718. ZIMMER ALLEN PLUG CAT#00801102024 LOT#63943174. REFOBACIN BONE CEMENT CAT#3020830401-3 LOT# A738AA0212. REPORT SOURCE: FOREIGN COUNTY: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO LOCATION OF DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019-02724, 0002648920-2019-00482.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 1 YEAR POST IMPLANTATION DUE TO MALALIGNMENT. IT WAS NOTED THAT ALL PRODUCT WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537742 SHELL WITH CLUSTER HOLES POROUS 54 MM O.D. SIZE JJ PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 63835532

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R