BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR NECK G1 12/14 NECK TAPER USE WITH +0 HEADS ONLY

    MDR report key: 9368401 · Received November 25, 2019

    Report

    Report Number
    0001822565-2019-05023
    Event Type
    Injury
    Date Received
    November 25, 2019
    Report Date
    February 2, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K071856
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: CAT# 1217-20-050 DEPUY CUP LOT# 835FCI000; CAT# 1221-32-450 DEPUY LINER LOT# E1HAAI000; CAT# 1217-30-500 DEPUY BONE SCREW LOT# 430943; CAT# 1217-20-500 DEPUY BONE SCREW LOT# 432370.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRIMARY SURGERY NOTES PROVIDED STATE NO INTRAOPERATIVE COMPLICATIONS. REVIEW OF DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING FOR THE REPORTED PART AND LOT COMBINATIONS. ZIMMER BIOMET COMPONENTS WERE USED WITH COMPETITOR PRODUCTS AND IS NOT AN APPROVED COMBINATION TO BE USED. THE ROOT CAUSE IS ATTRIBUTED TO USER ERROR/OFF LABEL USE. IT IS UNKNOWN IF THESE OFF-LABEL USAGES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. 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- UNKNOWN LINER, PN: UNKNOWN LN: UNKNOWN, UNKNOWN HEAD, PN: UNKNOWN LN: UNKNOWN, UNKNOWN STEM, PN: UNKNOWN LN: UNKNOWN. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY APPROXIMATELY NINE YEARS AGO. SUBSEQUENTLY, IT IS ALLEGED PATIENT IS SUFFERING FROM PAIN AND OTHER UNKNOWN COMPLICATIONS AFTER IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167368 MODULAR NECK G1 12/14 NECK TAPER USE WITH +0 HEADS ONLY PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 61585803
    1167369 MODULAR NECK G1 12/14 NECK TAPER USE WITH +0 HEADS ONLY PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 61585803

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SEE H10 NARRATIVE