BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 58G

    MDR report key: 18924071 · Received March 18, 2024

    Report

    Report Number
    0001825034-2024-00751
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    November 1, 2021
    Report Date
    April 25, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304524255
    PMA / PMN Number
    K121874
    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: 30103607 G7 VIT E NEUTRAL LNR 36MM G 64986276. 00877503604 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, ø 36/+7, TAPER 12/14 3044037. 574202050 AVENIR CMPL HA HO COL SIZE 5 3050331. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED 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. 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 COMPLETED. 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. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017124 G7 PPS LTD ACET SHELL 58G PROSTHESIS, HIPS PBI ZIMMER BIOMET, INC. N/A 6911164 00880304524255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H10 NARRATIVE