BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH

    MDR report key: 15438955 · Received September 16, 2022

    Report

    Report Number
    0002648920-2022-00192
    Event Type
    Injury
    Date Received
    September 16, 2022
    Date of Event
    August 22, 2022
    Report Date
    October 28, 2022
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    UDI-DI
    00889024119857
    PMA / PMN Number
    K934765
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000664- G7 PPS LTD ACET SHELL 54F- 7234417, 20104006- G7 LONGEVITY NEUTRAL 40MM F- 65462148, 574102020- AVENIR CMPL HA HO NC SIZE 2- 3080141, 00877504002- BIOLOX DELTA HEAD 12/14 40X0- 3083541. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT REMAINS IMPLANTED. 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. REPORTED EVENT WAS CONFIRMED VIA MEDICAL RECORDS AND RADIOGRAPHS REVIEWED BY HEALTH CARE PROFESSIONAL. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 ONE OF THE SCREWS WENT THROUGH THE CUP. NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER AN INITIAL HIP PROCEDURE, THE SCREW MIGRATED THROUGH THE CUP. SURGEON WAS NOT CONCERNED OVER THE MIGRATED SCREW. THE SCREW WAS PLACED FOR EXTRA PRECAUTION DURING THE PROCEDURE. NO PLANNED INTERVENTION. 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
    177286 BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 63983534 00889024119857

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other SEE H10 NARRATIVE