BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM COCR MOD HD +6MM NO SKIRT

    MDR report key: 10830859 · Received November 12, 2020

    Report

    Report Number
    0001825034-2020-04089
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    March 4, 2014
    Report Date
    November 24, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K974558
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS IDENTIFIED THE FOLLOWING : THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY. THE PATIENT BEGAN EXPERIENCING INSTABILITY AND RECURRENT DISLOCATIONS AND UNDERWENT A REVISION PROCEDURE ON DURING WHEN, ZIMMER BIOMET COMPONENTS WERE IMPLANTED. THE PATIENT UNDERWENT ANOTHER REVISION PROCEDURE DUE TO FAILED HIP ARTHROPLASTY. THE PATIENT WAS SUFFERING FROM PAIN AND THERE WAS SIGNIFICANT BONE LOSS. MRI REVEALED OSTEOLYSIS IN THE HIP JOINT. THE SHELL WAS FOUND TO BE LOOSE AND TRAPPED IN THE ACETABULUM MEDIAL DEFECT. HETEROTOPIC OSSIFICATION HAD FORMED POSTERIORLY AROUND POSTERIOR INFERIOR AND SUPERIOR ASPECT OF THE SHELL. THE STEM WAS WELL FIXED BUT THERE WAS EXTENSIVE CALCAR RESORPTION AND PROXIMAL FEMUR RESORPTION BELOW THE COLLAR OF THE STEM. THE LEG LENGTH WAS NOT CORRECTED. HEAD, LINER AND CUP WERE REPLACED WITH NEW ZIMMER BIOMET COMPONENTS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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: 166025 INTEGRAL REVISION 15X225MM LF 317640. 11-103548 UNIV RNGLC SHL 48MM/L22 130300. 11-105902 ARCOM 28MM RNGLOC LNR HWALL 258460. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. 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: 0001825034 - 2020 - 03096. 0001825034 - 2020 - 03097.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED TRAUMATIC LEFT HIP INJURY AT AGE (B)(6) AND HAD A CUP ARTHROPLASTY PERFORMED. NINE YEARS LATER, THE PATIENT TRIPPED AND FELL. THE FALL TRAUMA RESULTED IN A FULL LEFT HIP REPLACEMENT. THE PATIENT WAS REVISED SEVEN YEARS POST INITIAL FULL HIP REPLACEMENT DUE TO PAIN, RECURRENT DISLOCATIONS AND INSTABILITY. PATIENT REVISED AGAIN TWENTY FOUR YEARS POST FULL THA DUE TO PAIN AND PELVIC BONE FRACTURE. SHE WAS TOLD HER HIP STEM WAS TOO LONG AND SHE WALKED ON IT WRONG FOR YEARS CAUSING HER PELVIC TO SNAP. DURING THE REVISION HER SURGEON WAS UNABLE TO REMOVE THE STEM DUE TO IT BEING TOO DEEP. HE OPTED TO REVISE HER ACETABULAR SIDE TO COMPENSATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293683 28MM COCR MOD HD +6MM NO SKIRT PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 206300

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R