BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK CUP

    MDR report key: 8284516 · Received January 29, 2019

    Report

    Report Number
    0001825034-2019-00368
    Event Type
    Injury
    Date Received
    January 29, 2019
    Date of Event
    February 23, 2017
    Report Date
    August 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IMPLANT DATE UNKNOWN. CONCOMITANT MEDICAL PRODUCTS : UNKNOWN HEAD ¿ UNKNOWN PART AND LOT, UNKNOWN LINER ¿ UNKNOWN PART AND LOT, UNKNOWN STEM ¿ UNKNOWN PART AND LOT. MANUFACTURE DATE UNKNOWN.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES, LAB TESTS, AND X-RAY RESULTS NOTING FEELINGS OF INSTABILITY, INCREASING PAIN, SIGNIFICANT AMOUNT OF POLY WEAR, AND LARGE CAVITY DEFECTS TO THE POSTERIOR WALL OF THE ACETABULUM. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 6 YEARS POST IMPLANTATION, AND ANOTHER APPROXIMATELY 4 MONTHS AFTER THAT. SUBSEQUENTLY, THE PATIENT UNDERWENT A THIRD REVISION APPROXIMATELY 7 MONTHS LATER DUE TO PAIN AND INSTABILITY. DURING THE PROCEDURE, SIGNIFICANT AMOUNTS OF POLYETHYLENE WEAR WAS NOTED ALONG WITH LARGE CAVITY DEFECTS TO THE POSTERIOR WALL WHERE THERE WAS PREVIOUSLY METAL-ON-METAL RESORPTION.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: ITEM # EP-200154, ACT ARTIC E1 HIP BRG, LOT # 783280; ITEM # 11-104110, MLRY-HD POR FMRL, LOT # 625610; ITEM # 163666, 28MM DIA COCR MOD HD, LOT # 243760. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. RADIOGRAPH REVIEW STATES THE ALIGNMENT AND FIT APPEAR APPROPRIATE. NO HARDWARE COMPLICATION. PERIPROSTHETIC REGIONS APPEAR NORMAL WITHOUT LUCENCY OR OTHER ABNORMALITY. BONES ARE WELL MINERALIZED WITHOUT FRACTURE OR DISLOCATION. MILD AMOUNT OF HETEROTOPIC BONE (VERSUS CHRONICALLY NON-UNITED FRACTURE FRAGMENT) NOTED SUPERIOR TO THE RIGHT GREATER TROCHANTER. NO DISLOCATION OR FRACTURE. SOFT TISSUES GROSSLY NORMAL. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE PRODUCT WAS NON-CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. 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. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03031, 0001825034-2019-00368, 0001825034-2019-00369.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 7.5 YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79759 UNK CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 424700

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R