BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 15 HOLES, 324 MM

    MDR report key: 8581308 · Received May 6, 2019

    Report

    Report Number
    0009613350-2019-00279
    Event Type
    Injury
    Date Received
    May 6, 2019
    Date of Event
    March 28, 2019
    Report Date
    November 5, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    PMA / PMN Number
    K100111
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND THIS CASE HAS BEEN RE-OPENED. THE INVESTIGATION RESULTS HAVE BEEN UPDATED. DHR REVIEW: THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. TREND ANALYSIS: NO TRIGGER CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: PLATE BREAKAGE NO LOT TRIGGER: NO SIMILAR INVESTIGATED EVENTS FOR THE SAME LOT NUMBER 2970099 HAVE BEEN FOUND. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE NCB PLATE BROKE DUE TO A FALL. THE PATIENT FELL AND THEREBY THE PLATE BROKE. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. CONCLUSION SUMMARY IT WAS REPORTED THAT THE NCB PLATE BROKE DUE TO A FALL. THE PATIENT FELL AND THEREBY THE PLATE BROKE. THE IN VIVO TIME IS UNKNOWN. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT WERE RECEIVED. THEREFORE, THE CONDITION OF THE COMPONENT IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED AGAIN. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    DHR REVIEW: THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. TREND ANALYSIS: NO TRIGGER CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: PLATE BREAKAGE EVENT DESCRIPTION: IT WAS REPORTED THAT THE NCB PLATE BROKE DUE TO A FALL. THE PATIENT FELL AND THEREBY THE PLATE BROKE. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICE ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THIS DEVICE IS INTENDED FOR TREATMENT. CONCLUSION: IT WAS REPORTED THAT THE NCB PLATE BROKE DUE TO A FALL. THE PATIENT FELL AND THEREBY THE PLATE BROKE. THE IN VIVO TIME IS UNKNOWN. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT WERE RECEIVED. THEREFORE, THE CONDITION OF THE COMPONENT IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO EVENT UPDATE.

    Description of Event or Problem · 0

    PLEASE REFER TO REPORT 0009613350-2019-00279.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE NCB FEMUR PLATE BROKE DUE TO FALL OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374380 NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 15 HOLES, 324 MM NCB PERIPROSTHETIC PROXIMAL FEMUR PLATE, STERILE, RIGHT, 15 HOLES, L. 324 MM HRS ZIMMER GMBH N/A 2970099

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other