BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/P

    MDR report key: 6824789 · Received August 28, 2017

    Report

    Report Number
    0001822565-2017-06122
    Event Type
    Injury
    Date Received
    August 28, 2017
    Report Date
    December 27, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PK113296
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001822565 - 2017 - 06121, 0001822565 - 2017 - 06122. CONCOMITANT MEDICAL PRODUCTS: P/N 00625006520 BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH L/N 6307619, P/N 00223200400 TENSION RETAINING DEVICE L/N 62014237, P/N 00875705002 SHELL WITH MULTI HOLES POROUS 50 MM O.D. SIZE HH FOR USE WITH HH LINERS L/N 62700761, P/N 00999601735 FEMORAL BODY - REVISION - NITRIDED - POROUS CEMENTLESS 12/14 NECK TAPER STANDARD 40 MM NECK OFFSET, L/N 62972326 P/N 00801803203 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER L/N 62694670. IT HAS NOT BEEN REPORTED THE DEVICES HAVE BEEN REVISED; THE DEVICES CANNOT BE RETURNED FOR EVALUATION AT THE TIME OF THIS REPORTING. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. STILL IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A HIP ARTHROPLASTY TWO YEARS AGO AND IS EXPERIENCING SYMPTOMS OF METALLOSIS, PSEUDOTUMOR, PAIN, DEBILITATION, AND TRUNNIONOSIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603781 ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/P PROSTHESIS, HIP KWZ ZIMMER, INC. N/A 62972326

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention