BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN, DISTAL PART, CURVED, UNCEMENTED, 16/140

    MDR report key: 14237384 · Received April 28, 2022

    Report

    Report Number
    0009613350-2022-00262
    Event Type
    Injury
    Date Received
    April 28, 2022
    Date of Event
    January 17, 2022
    Report Date
    November 28, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    UDI-DI
    00889024592957
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL PRODUCT: REVITAN®, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 55, TAPER 12/14, CATALOG#: 01.00402.055; LOT#: 2828230. X-RAYS, PHOTOGRAPHS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2022-00258 (B)(4). IN TRANSIT TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10 - MEDICAL DEVICES: BIOLOX DELTA CERAMIC FEMORAL HEAD, 32MM, 12/14; ITEM# 00877503202; LOT# 2880842. THE BROKEN STEM WAS RETURNED FOR EXAMINATION WITH THE HEAD STILL MOUNTED ON THE STEM TAPER. THE HEAD LOOKS INCONSPICUOUS WITH SOME SLIGHT METALLIC SMEARING DERIVING MOST LIKELY FROM THE REMOVAL. THE CONNECTION PIN OF THE DISTAL STEM IS FRACTURED. THE FRACTURE SURFACES SHOW A FATIGUE FRACTURE WITH TYPICAL PROGRESSION LINES STARTING FROM THE LATERAL SIDE OF THE PIN. THE PROXIMAL COMPONENT EXHIBITS NO BONE ONGROWTH. SCRATCHES AND NICKS CAN BE SEEN, POSSIBLY DERIVING FROM THE REVISION SURGERY. PATTERNS OF SMALL POLISHED STRIPES ARE VISIBLE IN THE MEDIAL SIDE. THE DISTAL COMPONENT SHOWS DAMAGE CONSISTING OF SCRATCHES AND DENTS POSSIBLY DERIVING FROM THE REVISION SURGERY AS WELL AS A CUT AND A DRILLED AREA. BONE ATTACHMENTS ARE VISIBLE ON BOTH SURFACES. THE SURFACE OF THE DISTAL COMPONENT CLOSE TO THE PIN IS ALSO DAMAGED WITH VISIBLE MATERIAL DEFORMATION, PROBABLY DUE TO REMOVAL OF THE DISTAL PART DURING REVISION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. EXAMINATION OF THE PROVIDED PHOTOGRAPHS IDENTIFIED A PIN FRACTURE OF THE DISTAL REVITAN STEM. THE FRACTURE OF THE PIN IS LOCATED AT THE JUNCTION BETWEEN THE PROXIMAL AND DISTAL REVITAN STEM. THE FRACTURE SURFACES ARE NOT VISIBLE IN ANY OF THE PHOTOGRAPHS. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICES ARE USED FOR TREATMENT. A REVIEW OF THE SURGICAL REPORTS OF THE IMPLANTATION AND REVISION REVEALED THAT THE LEFT HIP STEM WAS INITIALLY REPLACED WITH A REVITAN STEM, DUE TO INSUFFICIENT OSTEOINTEGRATION AND PERSISTENT PAIN. CONSEQUENTLY, THE IMPLANTED REVITAN STEM WAS REVISED DUE TO IMPLANT FRACTURE WITH PERIPROSTHETIC FRACTURE. DURING REVISION SURGERY, THE PROXIMAL STEM WAS FOUND NOT TO BE OSTEOINTEGRATED, WHILE THE DISTAL STEM WAS WELL FIXED. THE RADIOGRAPHS OBTAINED DO NOT PROVIDE ANY ADDITIONAL INFORMATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DOCTOR INFORMED CASE OF A BROKEN REVITAN SHAFT. THE DATE OF THE REPLACEMENT SURGERY IS SCHEDULED FOR (B)(6) 2022. PATIENT OUTCOME - REVISION DUE TO IMPLANT FRACTURE.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109767 REVITAN, DISTAL PART, CURVED, UNCEMENTED, 16/140 HIP PROSTHESIS KWA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2868071 00889024592957

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| H SEE H10 NARRATIVE| SEE H10 NARRATIVE.