BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 SCREW

    MDR report key: 8339218 · Received February 14, 2019

    Report

    Report Number
    0001825034-2019-00642
    Event Type
    Injury
    Date Received
    February 14, 2019
    Report Date
    February 13, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    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 · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET G7 DUAL MOBILITY LINER 46MM G, ITEM #: 110024465, LOT #: 742780, BIOMET ACT ARTIC E1 HIP BRG 28X46MM ITEM #: EP-200152, UNKNOWN LOT NUMBER, ZIMMER MS-30®, STEM, STANDARD, CEMENTED, 12, TAPER 12/14, ITEM #: 300049120, LOT#: 2856985, ZIMMER COCR HEAD 28/-4 'S' 12/14, ITEM #: 14280520, LOT#: 2902809, ZIMMER MS-30®, DISTAL CENTRALIZER, CEMENTED, ø 12/14 ITEM #: 0100351214, LOT#: 2860360 REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, BECAUSE WAS SENT TO AN EXTERNAL CONTRACTOR. REVIEW OF INVOICE HISTORY WAS UNABLE TO DETERMINE THE EXACT IDENTIFICATION OF THE DEVICE INVOLVED IN THE REPORTED EVENT. THIS REPORT IS BEING SUBMITTED FOR: BRAND NAME - G7 SCREW 6.5MM X 15MM, CATALOG NUMBER ¿ 010000996, LOT NUMBER - 6091320, EXPIRATION DATE ¿ 7/11/2027, (B)(4), DEVICE MANUFACTURE DATE - 7/1/2017 OR BRAND NAME ¿ G7 SCREW 6.5MM X 35MM , CATALOG NUMBER ¿ 010001000 , LOT NUMBER - 6077768, EXPIRATION DATE ¿ 6/14/2027, (B)(4), DEVICE MANUFACTURE DATE - 6/1/2017, OR BRAND NAME ¿ G7 SCREW 6.5MM X 20MM, CATALOG NUMBER ¿ 010000997, LOT NUMBER ¿ 3181726, EXPIRATION DATE ¿ 10/30/2023 , (B)(4), DEVICE MANUFACTURE DATE -10/01/2013. OR BRAND NAME ¿ G7 SCREW 6.5MM X 35MM , CATALOG NUMBER ¿ 010001000, LOT NUMBER ¿ 3823755 , EXPIRATION DATE ¿ 6/28/2026, (B)(4), DEVICE MANUFACTURE DATE -6/1/2016. OR BRAND NAME ¿G7 SCREW 6.5MM X 20MM , CATALOG NUMBER ¿ 010000997, LOT NUMBER ¿ 6048899, EXPIRATION DATE ¿ 5/2/2027, (B)(4) , DEVICE MANUFACTURE DATE -5/1/2017. REPORTED EVENT WAS CONFIRMED BY REVIEW OF XRAYS. XRAY REVIEW INDICATED RIGHT TOTAL HIP ARTHROPLASTY WITH BROKEN ACETABULAR CUP SCREW. TRANSVERSE FRACTURE RIGHT ACETABULUM. NONSPECIFIC SOFT TISSUE MASS ANTERIOR/LATERAL TO THE RIGHT HIP. DIFFERENTIAL CONSIDERATIONS FOR IMAGING FINDINGS INCLUDE PSEUDOTUMOR ASSOCIATED WITH HIP ARTHROPLASTY AND FRACTURE DUE TO GRANULOMATOUS OSTEOLYSIS, POSSIBLE HEMATOMA ASSOCIATED WITH TRAUMATIC HIP FRACTURE AND OSTEOMYELITIS WITH A WEAKENING OF THE BONE, FRACTURE, AND ABSCESS. THE LARGE ISLAND OF HETEROTOPIC BONE LATERAL TO THE RIGHT HIP. GENERALIZED OSTEOPENIA. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02397 - 1.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT HIP REVISION APPROXIMATELY 19 MONTHS POST-IMPLANTATION DUE TO PELVIC FRACTURE AFTER A FALL. XRAY REVIEW INDICATED SCREW FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133211 G7 SCREW PROSTHESIS HIP PBI ZIMMER BIOMET, INC. N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R