BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 4326892 · Received December 12, 2014

    Report

    Report Number
    0001825034-2014-09094
    Event Type
    Injury
    Date Received
    December 12, 2014
    Report Date
    November 14, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. BRAND NAME - UNKNOWN. CATALOG NUMBER, LOT NUMBER AND EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY MATS SALEMYR, OLLE MUREN, THOMAS EISLER, HENRIK BODÉN, GHAZI CHAMMOUT, ANDRÉ STARK, & OLOF SKÖLDENBERG; INTERNATIONAL ORTHOPAEDICS (SICOT) DOI 10.1007/S00264-014-2571-Z. 510K NUMBER - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY THAT THE PATIENTS REFERENCED IN THE JOURNAL ARTICLE ASSOCIATED WITH THIS MANUFACTURER REPORT NUMBER ARE IN THE SAME STUDY GROUP OF PATIENTS REFERENCED IN THE JOURNAL ARTICLE ASSOCIATED WITH 1825034-2015-01202.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO ADDRESS ONLY ONE EVENT OF THE ARTICLE. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/ UPDATED INFORMATION. EVENT DESCRIPTION, EVALUATION CODES, MANUFACTURER NARRATIVE. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "POROUS TITANIUM CONSTRUCT CUP COMPARED TO POROUS COATED TITANIUM CUP IN TOTAL HIP ARTHROPLASTY. A RANDOMIZED CONTROLLED TRIAL." THE PURPOSE OF THIS STUDY WAS TO DETERMINE IF A NEW TITANIUM CUP WITH INCREASED POROSITY RESULTED IN DIFFERENT PERIACETABULAR BONE LOSS AND MIGRATION COMPARED TO A POROUS COATED CUP. THE STUDY WAS CONDUCTED OVER A PERIOD OF FOUR (4) YEARS (OCTOBER 2009 TO AUGUST 2013) AND INVOLVED FIFTY-ONE (51) PATIENTS. TWENTY-FIVE (25) PATIENTS RECEIVED A CUP WITH POROUS TITANIUM CONSTRUCT BACKSIDE AND TWENTY-SIX (26) PATIENTS RECEIVED A CONVENTIONAL POROUS COATED TITANIUM CUP. PATIENTS IN THE POROUS TITANIUM GROUP RECEIVED AN ACETABULAR SHELL WITH A BACKSIDE OF A 3D POROUS TITANIUM (REGENEREX¿-SHELL, E1¿-LINER MANUFACTURED BY BIOMET). THE CONVENTIONAL POROUS COATED TITANIUM CUP WAS OF COMPETITOR MANUFACTURE. ONE PATIENT IN THE POROUS TITANIUM GROUP REPORTED INCREASING HIP PAIN STARTING SEVERAL MONTHS AFTER SURGERY. RADIOLUCENT LINES WERE VISIBLE ALONG THE STEM BUT NOT BEHIND THE CUP. DURING REVISION SURGERY, A LOW VIRULENT DEEP PERIPROSTHETIC INFECTION COULD BE VERIFIED. ONE DEATH WAS ALSO REPORTED, BUT IT IS UNKNOWN WHOSE PRODUCT WAS IMPLANTED. AND IT IS STATED THAT THE DEATH WAS UNRELATED TO THE SURGERY. THE AUTHORS OF THE STUDY CONCLUDE, ¿THE CUPS USED FOR BOTH THE POROUS TITANIUM GROUP AND THE CONTROL GROUP CONSERVED THE PERIACETABULAR BONE AFTER 24 MONTHS¿ AND ¿FIXATION OF THE SHELL USED IN THE POROUS TITANIUM GROUP IS, UP TO TWO YEARS, AS GOOD AS THE WELL-PROVEN AND CLINICALLY WELL FUNCTIONING CUP USED FOR THE CONTROL GROUP.¿

    Description of Event or Problem · 1

    WAS OBSERVED IN THE JOURNAL ARTICLE THAT ONE PATIENT (1) WAS REVISED DUE TO PAIN. INITIALLY, IT WAS ALSO REPORTED THAT THE PATIENT HAD INCREASING HIP PAIN WHICH STARTED SEVERAL MONTHS (UNKNOWN DURATION) AFTER THE SURGERY. DURING REVISION SURGERY, A LOW VIRULENT DEEP PERI-PROSTHETIC INFECTION COULD BE VERIFIED. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENTS OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808522 UNKNOWN HIP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R