BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL, ø 36/+7, TAPER 12/14

    MDR report key: 18928621 · Received March 19, 2024

    Report

    Report Number
    0009613350-2024-00109
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    November 1, 2021
    Report Date
    June 4, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024430389
    PMA / PMN Number
    K192416
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: G7 PPS LTD ACET SHELL 58G ITEM #010000666 LOT# 6911164 36MM I.D. SIZE G NEUTRAL LINER ITEM # 30103607 LOT #64986276 FEMORAL STEM CEMENTLESS COLLARED HIGH OFFSET 12/14 TAPER SIZE 5 ITEM # 574202050 LOT# 3050331 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A HEMATOMA IS A MASS OF CLOTTED BLOOD THAT FORMS IN A TISSUE, ORGAN, OR BODY SPACE. A HEMATOMA CAN BE ASSOCIATED WITH PAIN, SWELLING, ECCHYMOSIS, SEROSANGUINOUS OR BLOODY DRAINAGE AFTER A RECENT SURGICAL PROCEDURE OR TRAUMA AND CAN PREDISPOSE THE PATIENT TO INFECTION. THE DEVELOPMENT OF A POSTOPERATIVE HEMATOMA CAN BE CORRELATED WITH THE SURGICAL PROCEDURE AND PERIOPERATIVE ANTICOAGULATION THERAPY PRESCRIBED TO PREVENT THROMBUS FORMATION. MOST HEMATOMAS RESOLVE ON THEIR OWN, WITHOUT SURGICAL INTERVENTION, WHILE SOME DO NOT. LARGER HEMATOMAS MAY NEED TO BE SURGICALLY EVACUATED IN ORDER TO RESOLVE. AS TIMEFRAMES OF ONSET DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE CANNOT BE ESTABLISHED. LOW BLOOD PRESSURE OCCURS WHEN BLOOD PRESSURE IS MUCH LOWER THAN NORMAL. THIS MEANS THE HEART, BRAIN, AND OTHER PARTS OF THE BODY MAY NOT GET ENOUGH BLOOD. NORMAL BLOOD PRESSURE IS MOSTLY BETWEEN 90/60 MMHG AND 120/80 MMHG. THE MEDICAL WORD FOR LOW BLOOD PRESSURE IS HYPOTENSION. LOW BLOOD PRESSURE IS ONLY A PROBLEM IF IT HAS A NEGATIVE IMPACT ON THE BODY AND PRODUCES SYMPTOMS. SOME CAUSES OF HYPOTENSION INCLUDE BLOOD LOSS, DEHYDRATION AND CERTAIN MEDICATIONS, SUCH AS PAIN OR ANTIHYPERTENSIVE DRUGS. THE MOST COMMON SYMPTOM OF ORTHOSTATIC HYPOTENSION IS LIGHTHEADEDNESS OR DIZZINESS WHEN STANDING AFTER SITTING OR LYING DOWN. SYMPTOMS USUALLY LAST LESS THAN A FEW MINUTES. ORTHOSTATIC HYPOTENSION CAN HAVE CAUSES THAT AREN'T DUE TO UNDERLYING DISEASE. EXAMPLES INCLUDE DEHYDRATION, STANDING UP TOO QUICKLY, MEDICATION SIDE EFFECTS, OR AGING. TREATMENT DEPENDS ON THE CAUSE. FOR EXAMPLE, THE DOSAGES OF EXISTING MEDICATIONS MAY NEED TO BE ALTERED OR A BLEEDING STOMACH ULCER SURGICALLY REPAIRED. IF NO PARTICULAR CAUSE CAN BE FOUND, DRUGS MAY BE USED TO RAISE BLOOD PRESSURE. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE IMPLANTED ZIMMER BIOMET DEVICE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, PRIOR TO OUTPATIENT DISCHARGE, POST-OPERATIVE ORTHOSTATIC HYPOTENSION AND A RIGHT POSTEROLATERAL HEMATOMA WERE NOTED. THE PATIENT WAS TRANSFERRED FROM THE SURGERY CENTER AND ADMITTED TO A HOSPITAL FACILITY FOR OBSERVATION AND MEDICAL INTERVENTION. SYMPTOMS RESOLVED AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. THE STUDY HAS SINCE BEEN COMPLETED PER PROTOCOL WITH NO FURTHER COMPLICATIONS OR ALLEGATIONS AGAINST THE DEVICE, ALL INITIAL PRODUCT REMAINS IMPLANTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2342836 BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL, ø 36/+7, TAPER 12/14 HIP IMPLANT LZO ZIMMER GMBH N/A 3044037 00889024430389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H10 NARRATIVE