BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX60MM CUP

    MDR report key: 10786500 · Received November 4, 2020

    Report

    Report Number
    0001825034-2020-04004
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    November 17, 2004
    Report Date
    November 4, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 113848 ¿ TITANIUM SCREW ¿ 503370. X180314 ¿ BI-METRIC STEM ¿ 308810. 11-173665 ¿ M2A HEAD - 527970. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBID STATE, AND PERIOPERATIVE MANAGEMENT.FACILITIES HAVE DISCHARGE CRITERIA THAT PATIENTS MUST MEET POST SURGICAL PROCEDURE. IF THE DISCHARGE CRITERIA ARE NOT MET, THEN THE PATIENT WILL BE KEPT UNTIL THEY ARE STABLE FOR DISCHARGE, AND FOR THEIR SAFETY. THE DELAYED/PROLONGED HOSPITALIZATION IS NOT ABNORMAL, AS SIDE EFFECTS FROM ANESTHESIA ARE COMMON AND TYPICALLY RESOLVE WITHIN 24-48 HOURS. AS THE COMPLAINT INDICATES, THE PATIENT EXPERIENCED PROCEDURE-RELATED POST-OPERATIVE HYPOTENSION RESULTING IN A BLOOD TRANSFUSION OF 2 UNITS TO INCREASE VOLUME AND BLOOD PRESSURE. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE IMPLANTED ZIMMER BIOMET DEVICE; THEREFORE, A COMPLAINT HISTORY REVIEW AND A PRODUCT HOLD/RECALL SEARCH WILL NOT BE PERFORMED. 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 - 2020 - 04006. 0001825034 - 2020 - 04005.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY, DURING THE IMMEDIATE POST-OP PERIOD THE PATIENT EXPERIENCED HYPOTENSION REQUIRING A BLOOD TRANSFUSION. THERE WERE NO FURTHER COMPLICATIONS NOTED. 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
    1252470 M2A 38MMX60MM CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 011150

    Patients

    Seq Age Sex Outcome Treatment
    1 Other