BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI MULTIHOLE 52MM E

    MDR report key: 10491061 · Received September 3, 2020

    Report

    Report Number
    0001825034-2020-03434
    Event Type
    Injury
    Date Received
    September 3, 2020
    Date of Event
    August 19, 2020
    Report Date
    November 11, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY AND IT WAS DETERMINED THAT THE FOLLOWING IMPLANTS ARE NOT COMPATIBLE: 110010264 6112808 G7 OSSEOTI MULTIHOLE 52MM E 00662406515 63663356 BONE SCREW SELF-TAPPING 15 MM LENGTH 6.5 MM DIA. 00662406520 62748097 BONE SCREW SELF-TAPPING 20 MM LENGTH 6.5 MM DIA. 00662406525 63896220 BONE SCREW SELF-TAPPING 25 MM LENGTH 6.5 MM DIA. RADIOGRAPH REVIEW IDENTIFIED: LEFT TOTAL HIP ARTHROPLASTY WITH GROSSLY ABNORMAL APPEARANCE OF THE ACETABULAR CUP WHICH APPEARS TO BE LOOSE IN POSITION OUTSIDE OF THE ACETABULAR REGION DESPITE MULTIPLE SCREWS. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #: UNKNOWN, UNKNOWN HEAD LOT #: UNKNOWN. ITEM #: UNKNOWN, UNKNOWN STEM LOT #: UNKNOWN. 010000896 G7 10 DEG E1 LINER 36MM 6105239. 00489405010 TRABECULAR ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT 63775289. 00662406515 BONE SCREW SELF-TAPPING 15 MM 63663356. 00662406520 BONE SCREW SELF-TAPPING 20 MM 62748097. 00662406525 BONE SCREW SELF-TAPPING 25 MM 63896220. FOREIGN REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND WAS REVISED OVER A YEAR LATER DUE TO FIXATION FAILURE OF THE CUP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955464 G7 OSSEOTI MULTIHOLE 52MM E PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 6112808

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R