BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD STERILE PRODUCT TAPER

    MDR report key: 6180533 · Received December 16, 2016

    Report

    Report Number
    0002648920-2016-04385
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    November 18, 2016
    Report Date
    September 2, 2020
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    PK953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: (B)(4). D11: ITEM# 00771101000/ FEMORAL STEM 12/14 NECK TAPER / LOT # 62079457. ITEM # 00620205622/ SHELL POROUS /LOT # 62136137. ITEM# 00631005632/ LINER/ LOT# 62156742. PART # 00625006530/ BONE SCREW/ LOT # 62163451. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 -2016 -04692.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. REVIEW OF AVAILABLE RECORDS IDENTIFIED A REVISION SURGERY OCCURRED. MRI EXAM REVEALED ADVERSE LOCAL TISSUE REACTION. DURING THE PROCEDURE, THERE WAS CLOUDY YELLOW FLUID IN THE JOINT SPACE, AND SCAR TISSUE WAS OBSERVED BETWEEN THE MEDIUS AND TENSOR FASCIA LATA. THERE WAS A LARGE AMOUNT OF FIBROUS NONVIABLE DEBRIS. CORROSION AT THE HEAD-TRUNNION JUNCTION WAS NOTED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT HIP REVISION 4 YEARS POST IMPLANTATION DUE TO ELEVATED METAL ION LEVELS, ALTR, LOSS OF RANGE OF MOTION, PAIN, SCAR TISSUE, TISSUE DAMAGE, AND IN VIVO-CORROSION. HEAD COMPONENT WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    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) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS 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.

    Description of Event or Problem · 1

    IT IS REPORTED THA THE PATIENT WAS REVISED DUE TO ALVAL, METALLOSIS AND CORROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830812 FEMORAL HEAD STERILE PRODUCT TAPER PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 62178297

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R