BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 VIT E NEUTRAL LNR 36MM D

    MDR report key: 10785168 · Received November 4, 2020

    Report

    Report Number
    0001822565-2020-03726
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    September 9, 2020
    Report Date
    November 4, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K190660
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000662-G7 PPS LTD ACET SHELL 50D-6727744; 00877503602- BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14- 2993410; 0106010003- AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 3, TAPER 12/14- 2966718. 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. ANEMIA IS A CONDITION THAT DEVELOPS WHEN YOUR BLOOD IS DEFICIENT IN RED BLOOD CELLS (HEMOGLOBIN), WHICH LIMITS THE HEMOGLOBIN'S ABILITY TO CARRY ENOUGH OXYGEN THROUGHOUT THE BODY'S SYSTEM. WITH THE LACK OF OXYGEN, THE PATIENT CAN EXPERIENCE, LIGHT HEADEDNESS, WEAKNESS, FATIGUE, FAINTING, DIZZINESS, ELEVATED HEART RATE. ANEMIA CAN BE ASSOCIATED WITH DIFFERENT MEDICAL CONDITIONS OR CAN BE DIRECTLY RELATED TO BLOOD LOSS DURING A TRAUMA, SURGICAL PROCEDURE OR SURGICAL COMPLICATION. ANEMIA DEPENDING ON THE CAUSE CAN BE MONITORED AND TREATED MINIMALLY OR IF HEMOGLOBIN IS SIGNIFICANTLY LOW, IT COULD BE INDICATED THAT MEDICAL INTERVENTION IS NECESSARY TO TREAT, I.E. ADMINISTERING BLOOD OR OTHER MEDICAL INTERVENTIONS. AS POSTOPERATIVE DEVELOPMENT OF ANEMIA DEVELOPS WITH NO OTHER IDENTIFIED CAUSE, THIS SIGNIFIES A POSTOPERATIVE PROCEDURE-RELATED COMPLICATION. 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. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED POST-OPERATIVE ANEMIA AND HYPOTENSION REQUIRING MEDICAL INTERVENTION AND PROLONGED HOSPITALIZATION 2 DAYS¿ POST IMPLANTATION. 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
    1248783 G7 VIT E NEUTRAL LNR 36MM D PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64797263

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R