BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 46MM G

    MDR report key: 8543807 · Received April 24, 2019

    Report

    Report Number
    0001825034-2019-01826
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    March 29, 2019
    Report Date
    July 25, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 0100102618 WAGNER SL REVISION® HIP STEM, UNCEMENTED, ø 18/265, TAPER 12/14 LOT# 2934288. 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.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS AND XRAYS WHICH INDICATED MULTIPLE DISLOCATIONS. VISUAL INSPECTION OF THE BEARING IDENTIFIED LIGHT SCRATCHES ON THE LIP OF THE OPEN END ALL ALONG THE BACKSIDE. THERE WERE ALSO GOUGES OR INDENTATIONS THAT CAN BE FELT WITH THE FINGERNAIL ON THE OUTER DIAMETER. DIMENSIONAL ANALYSIS CANNOT BE PERFORMED DUE TO THE NATURE OF DAMAGES DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 0

    (B)(4). 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

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    T WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL LEFT THA ON AN UNKNOWN DATE, AT AN UNKNOWN HOSPITAL, BY UNKNOWN SURGEON. THE PATIENT ACQUIRED AN INFECTION AND IN THE OTHER HOSPITAL, THEY REMOVED UNKNOWN PRODUCT IN A GIRDLESTONE PROCEDURE. SUBSEQUENTLY, PATIENT HAD REVISION OF THE LEFT THA TO TO ZIMMER BIOMET PRODUCT AND WAS REVISED APPROXIMATELY 8 DAYS LATER DUE TO TURNING IN BED AND DISLOCATING HIP. THE PATIENT WAS REDUCED WITHOUT REVISION. PATIENT DISLOCATED AGAIN APPROXIMATELY 45 DAYS LATER DURING X-RAYS AND WAS REDUCED AGAIN WITHOUT REVISION. SUBSEQUENTLY, THE PATIENT WAS REVISED 8 DAYS AFTER 2ND DISLOCATION AS SHE DISLOCATED AGAIN. THE LINER, HEAD, AND STEM WERE REVISED. DURING REVISION EVACUATION OF HEMATOMA -300ML-. PER XRAY PRIOR TO REVISION, FRACTURED GREATER TROCHANTER WITH PROXIMAL CERCLAGE WIRE AND AGE-INDETERMINATE FRACTURE INVOLVING THE LESSER TROCHANTER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE; HOWEVER, NONE WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# EP-200152 ACT ARTIC E1 HIP BRG 28X46MM LOT# 490510, ITEM# 010000666 G7 PPS LTD ACET SHELL 58G LOT# 6320695, ITEM# 00801802802 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER LOT# 64003482, ITEM# UNKNOWN UNKNOWN STEM LOT# UNKNOWN. REPORT SOURCE: (B)(6). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01828.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL LEFT THA ON AN UNKNOWN DATE, AT AN UNKNOWN HOSPITAL, BY UNKNOWN SURGEON. THE PATIENT ACQUIRED AN INFECTION AND IN THE OTHER HOSPITAL, THEY REMOVED UNKNOWN PRODUCT IN A GIRDLESTONE PROCEDURE. SUBSEQUENTLY, PATIENT HAD REVISION OF THE LEFT THA TO ZIMMER BIOMET PRODUCT AND WAS REVISED APPROXIMATELY 8 DAYS LATER DUE TO TURNING IN BED AND DISLOCATING HIP. THE PATIENT WAS REDUCED WITHOUT REVISION. PATIENT DISLOCATED AGAIN APPROXIMATELY 45 DAYS LATER DURING X-RAYS AND WAS REDUCED AGAIN WITHOUT REVISION. SUBSEQUENTLY, THE PATIENT WAS REVISED 8 DAYS AFTER 2ND DISLOCATION AS SHE DISLOCATED AGAIN. THE LINER, HEAD, AND STEM WERE REVISED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336444 G7 DUAL MOBILITY LINER 46MM G PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 143090

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R