BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX52MM CUP

    MDR report key: 7996869 · Received October 23, 2018

    Report

    Report Number
    0001825034-2018-09866
    Event Type
    Injury
    Date Received
    October 23, 2018
    Date of Event
    March 29, 2019
    Report Date
    April 24, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : POROUS INTEGRAL FEMORAL STEM CATALOG#: 162613 LOT#: 860250. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. X-RAY REVIEW CONFIRMS SUPERIOR DISLOCATION OF A LEFT TOTAL HIP ARTHROPLASTY, THE ACETABULAR INCLINATION ANGLE IS WITHIN NORMAL LIMITS. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 15 YEARS POST LEFT HIP SURGERY DUE TO DISLOCATION. CUP AND HEAD WAS REVISED. SIC MONTHS PRIOR TO THE REVISION SURGERY, THE PATIENT WAS ALSO SUFFERING WITH PAIN, SUBLUXATION, CYST, METAL DEBRIS AND POPPING NOISE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-173666 ¿ M2A HEAD - 277270. THERAPY DATE: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT IS STILL 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: 0001825034-2018-09869.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 4 YEARS POST IMPLANTATION. SUBSEQUENTLY, PATIENT IS BEING RECOMMENDED FOR A SECOND REVISION DUE TO PAIN, SUBLUXATION, CYST, METAL DEBRIS AND POPPING NOISE. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838539 M2A 38MMX52MM CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 370770

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R