BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD +3MM NK

    MDR report key: 6998617 · Received November 3, 2017

    Report

    Report Number
    0001825034-2017-09691
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    April 1, 2015
    Report Date
    May 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. MULTIPLE REPORTS ARE BEING SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-09691, 0001825034-2018-03328

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PATIENT IS A BILATERAL PATIENT. IT IS UNKNOWN WHICH DEVICES WERE IMPLANTED ON WHICH SIDE. 11-173663 M2A 38 MM MOD HD +3 MM NK LOT 444190 STERILE DATE: JUL 31, 2014 MANUFACTURE DATE: JUL 6, 2004. 11-173662 M2A 38 MM MOD HD STD NK LOT 429170 STERILE DATE: JUN 30, 2014 MANUFACTURE DATE: JUN 28, 2004. 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

    (B)(4). MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2017 - 09689, 0001825034 - 2017 - 09690, 0001825034 - 2017 - 09691. PATIENT IS A BILATERAL PATIENT. IT IS UNKNOWN WHICH DEVICES WERE IMPLANTED ON WHICH SIDE. 11-173663 M2A 38MM MOD HD +3MM NK LOT 444190, 11-173662 M2A 38MM MOD HD STD NK LOT 429170. CONCOMITANT MEDICAL PRODUCTS: PATIENT IS A BILATERAL PATIENT AND THE OTHER SET OF CUP, FEMORAL, AND NECK WILL BE REPORTED ON THE CMP-0336172. IT IS UNKNOWN WHICH DEVICES WERE IMPLANTED ON WHICH SIDE. RD118850 M2A 38MMX50MM CUP LOT 163980 RD118850 M2A 38MMX50MM CUP LOT 857690 21-103204 HA TAPERLOC POR FMRL 10X140 LOT 860160 21-103204 HA TAPERLOC POR FMRL 10X140 LOT 163850 11-173663 M2A 38MM MOD HD +3MM NK LOT 444190 11-173662 M2A 38MM MOD HD STD NK LOT 429170. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED IN LITIGATION THE PATIENT SUFFERED SYMPTOMS LEADING TO REVISION INCLUDING PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, HIGHLY ELEVATED METAL ION LEVELS, SEVERE METAL POISONING, METALLOSIS, AND METALLIC DEBRIS IN THE BODY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780405 M2A 38MM MOD HD +3MM NK PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R