BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI MULTIHOLE 58MM G

    MDR report key: 19097091 · Received April 12, 2024

    Report

    Report Number
    0001825034-2024-01005
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    April 3, 2024
    Report Date
    July 31, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00887868356056
    PMA / PMN Number
    K140669
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A2: DATE OF BIRTH: INFORMATION PROVIDED BY THE HOSPITAL SHOWED THE DATE OF BIRTH DOCUMENTED AS TWO DIFFERENT DATES: (B)(6) 1947 AND (B)(6) 1948. D10: CAT# 010000985 LOT# 7648566 G7 FREEDOM CONST E1 LNR 36MM G. CAT# 11-107021 LOT# 884560 FREEDOM CONSTR HD 36MM T1 +9MM. CAT# 010000997 LOT# 7681145 G7 SCREW 6.5MM X 20MM. CAT# 010000997 LOT# 7641778 G7 SCREW 6.5MM X 20MM. CAT# 010000999 LOT#7665793 G7 SCREW 6.5MM X 30MM. CAT# 010000999 LOT# 7633835 G7 SCREW 6.5MM X 30MM. CAT# 010000999 LOT# 7648566 G7 SCREW 6.5MM X 30MM. G2: FOREIGN: COUNTRY: AUSTRALIA. 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 INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4;G3;H2;H3;H6 NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS, SHELL, LINER, AND SCREWS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE NOT PROVIDED FOR THE EVENT RELATED TO THE REVISION DUE TO PELVIC FRACTURE LEADING TO CUP LOOSENING. HOWEVER, REVIEW OF THE AVAILABLE INFORMATION BY A HEALTH CARE PROFESSIONAL IDENTIFIED THE FOLLOWING: IT WAS REPORTED THAT PATIENT HAD A RIGHT HIP PERFORMED ON AN UNKNOWN DATE. PATIENT SUBSEQUENTLY HAD A RIGHT HIP REVISION DUE TO RECURRENT DISLOCATIONS AND ECCENTRIC POLY WEAR AND WAS THEN REVISED A SECOND TIME FOR RECURRENT DISLOCATIONS. THE PATIENT EXPERIENCED A PELVIC FRACTURE LEADING TO CUP LOOSENING WHICH RESULTED IN AN ADDITIONAL REVISION. CONTRIBUTING FACTORS TO THE BONE FRACTURE IS UNKNOWN. THE SHELL, LINER AND SCREWS WERE EXPLANTED, AND AN UNKNOWN ZIMMER BIOMET STEM WAS RETAINED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. UNABLE TO CONFIRM COMPLAINT. 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

    IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT HAD A RIGHT HIP REVISION APPROXIMATELY ONE MONTH AGO DUE TO RECURRENT DISLOCATIONS. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY A WEEKS AGO DUE TO A PELVIC FRACTURE WHICH LED TO CUP LOOSENING. IT WAS REPORTED THAT THE PELVIC FRACTURE WAS THOUGHT TO HAVE OCCURRED IN THE PREVIOUS REVISION. NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793941 G7 OSSEOTI MULTIHOLE 58MM G PROTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 66390801 00887868356056

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H