BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALL-POLY TRI POLAR CUP 26X60MM

    MDR report key: 7150931 · Received December 28, 2017

    Report

    Report Number
    0001825034-2017-11431
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    July 19, 2011
    Report Date
    May 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    PK991990
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOW UP REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED. 11-301351 ARCOS CON SZ A HI 80MM 983940, 11-165202 RLOC TRIPOLAR 41MMOD28MMIDSZ26 781610, 11-300615 ARCOS 15X200MM PRX TPR DIST 956670, 163662 28MM MOD HD STD NECK TP1 TAPER 063130. THE COMPLAINT WAS CONFIRMED BASED ON THE SURGICAL NOTES AND THE X-RAY THAT WERE PROVIDED. X-RAY REVIEW SHOWS SUPERIOR DISLOCATION. DEVICE HISTORY RECORDS WERE REVIEWED AND IDENTIFIED NO DEVIATIONS OR ANOMALIES RELEVANT TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01133.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A DISLOCATION AND CLOSED REDUCTION TWO MONTHS PRE OP. THE PATIENT WAS FREE OF DISLOCATION FOR THREE MONTH WITH ABDUCTION BRACE. HOWEVER, FOUR DAYS LATER, AFTER REMOVE THE ABDUCTION BRACE, THE PATIENT HAD ANOTHER DISLOCATION AND CLOSED REDUCTION. NOW THE PATIENT WAS REVISED DUE TO RECURRING DISLOCATIONS AND INSTABILITY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: 163662, 28MM MOD HD STD NECK TP1 TAPER, 063130; 11-301351, ARCOS CON SZ A HI 80MM, 983940.

    Additional Manufacturer Narrative · 1

    (B)4). DATE OF EVENT - MANUSCRIPT WAS WRITTEN IN 2017. CONCOMITANT PRODUCTS: UNKNOWN, UNKNOWN ARCOS DISTAL STEM, UNKNOWN. UNKNOWN, UNKNOWN ARCOS PROXIMAL STEM, UNKNOWN. UNKNOWN, UNKNOWN HEAD, UNKNOWN. UNKNOWN, UNKNOWN LINER, UNKNOWN. UNKNOWN, UNKNOWN CUP, UNKNOWN. REPORT SOURCE, LITERATURE - PELT, C.E. ET AL (2017). REVIEW OF A MODERN MODULAR FEMORAL REVISION STEM IN REVISION TOTAL HIP ARTHROPLASTY. UNPUBLISHED MANUSCRIPT, THE UNIVERSITY OF UTAH DEPARTMENT OF ORTHOPAEDICS, SALT LAKE CITY, UT. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO 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. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR RIGHT HIP DUE TO DISLOCATION AFTER STAGE I IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THREE PATIENTS WERE REVISED DUE TO INSTABILITY, AND REVISION OF THE STEM WAS LIMITED TO THE PROXIMAL BODY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930537 ALL-POLY TRI POLAR CUP 26X60MM PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 627910

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R