BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI 4 HOLE SHELL 60MM G 0MM G

    MDR report key: 9340492 · Received November 19, 2019

    Report

    Report Number
    0001825034-2019-05231
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    October 30, 2019
    Report Date
    February 27, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    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. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO SURGICAL PROCEDURE. THE SURGEON RECOMMENDED THE PATIENT BACK OFF OF PT INTENSITY TO ALLOW THE BODY TO RECOVER FROM THE TENDINITIS EXACERBATION THAT APPEARS TO BE INHIBITING ROM. AS THE COMPLAINT INDICATED A POST PROCEDURE COMPLICATION OCCURRED, IT CAN BE IMPLIED THAT MEDICAL INTERVENTION IN SOME FORM WAS IMPLEMENTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: REF110017187 LOT 6279288 G7 NEU +5MM ARCOMXL LNR 36MM G. REF 12115121 LOT 2971339 HEAD. REF 51104160 LOT 6531097 STEM. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MONTH AFTER INITIAL LEFT TOTAL HIP ARTHROPLASTY THE PATIENT SUFFERED FROM ILIOPSOAS BURSITIS . THE PATIENT WAS PLACED ON PRESCRIBED NSAIDS AND STEROIDS AND INSTRUCTED TO DECREASE PHYSICAL THERAPY INTENSITY AT THIS TIME. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134350 G7 OSSEOTI 4 HOLE SHELL 60MM G 0MM G PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 6214220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other