BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 32MM F

    MDR report key: 6735290 · Received July 24, 2017

    Report

    Report Number
    0001825034-2017-05171
    Event Type
    Injury
    Date Received
    July 24, 2017
    Date of Event
    June 5, 2017
    Report Date
    September 10, 2019
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    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 · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- PART: 163669 NAME: 32MM MOD HEAD COCR STD NECK LOT: 00J3489122. FOREIGN- (B)(6). THE INVESTIGATION IS STILL IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS COMPLAINT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05116.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS RECEIVED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THAT THE PATIENT BENT FORWARD TO TIE HER SHOES AND DISLOCATED. X-RAYS RECEIVED STATES THAT THERE IS LATERAL POSITIONING OF THE CUP WITH RESPECT TO THE PELVIS. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE INFORMATION FROM CLINICAL SUGGESTS THAT THE DISLOCATION WAS NOT RELATED TO THE DEVICE BUT WAS RELATED TO THE SURGICAL TECHNIQUE USED; THEREFORE THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO USE ERROR. 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 · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). CONCOMITANT MEDICAL PRODUCTS: G7 PPS LTD ACET SHELL 56F P/N 010000665 L/N 3445160, ECHO POR FMRL NC 11X135 P/N 192011 L/N 844220. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED AND OP NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. AN X-RAY REVIEW WAS PERFORMED :ASSESSMENT OF THE IMAGING STATES : LATERAL POSITIONING OF THE CUP WITHIN THE PELVIS. THIS MAY OFTEN GO ASYMPTOMATIC BUT CAN ALSO PREDISPOSE TO DISLOCATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 YEARS POST INITIAL IMPLANTATION DUE TO DISLOCATION/SUBLUXATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED LUXATION AND DISLOCATION APPROXIMATELY TWO YEARS POST IMPLANTATION AFTER BENDING FORWARD. PATIENT WAS TREATED WITH CLOSED REDUCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516344 G7 NEUTRAL E1 LINER 32MM F PROSTHESIS, HIP PBI BIOMET ORTHOPEDICS N/A 3423867

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R