BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN DISTAL STEM HIP IMPLANT

    MDR report key: 8542905 · Received April 24, 2019

    Report

    Report Number
    0009613350-2019-00246
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    April 9, 2019
    Report Date
    August 7, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. TREND ANALYSIS: ANALYSIS COULD NOT BE PERFORMED AS NO ITEM NUMBER IS AVAILABLE. EVENT SUMMARY: IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO IMPLANT FRACTURE. 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. REVIEW OF PRODUCT DOCUMENTATION THIS DEVICE IS INTENDED FOR TREATMENT. CONCLUSION SUMMARY: IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH REVITAN STEM ON (B)(6) 2005 AND REVISED ON (B)(6) 2019. THE IN VIVO TIME OF THE DEVICE IS 14 YEARS 1 MONTH. THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. THE COMPATIBILITY CHECK COULD NOT BE PERFORMED AS NO PRODUCT INFORMATION WAS PROVIDED. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). 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. 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING, A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN UNKNOWN REVITAN DISTAL STEM. SUBSEQUENTLY THE PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM# UNKNOWN, LOT# UNKNOWN, REVITAN DISTAL STEM HIP IMPLANT. ITEM# UNKNOWN, LOT# UNKNOWN, REVITAN PROXIMAL STEM HIP IMPLANT. PREMARKET IDENTIFICATION: THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K071723. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS THE REVISION HAS NOT YET BE PERFORMED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED IMPLANT BREAKAGE APPROXIMATELY 14 YEARS POST IMPLANTATION. A REVISION SURGERY HAS BEEN PLANNED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338575 REVITAN DISTAL STEM HIP IMPLANT N/A KWA ZIMMER GMBH N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE NARRATIVE IN H10