BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN, DISTAL PART, CURVED, UNCEMENTED, 24/200

    MDR report key: 17359099 · Received July 20, 2023

    Report

    Report Number
    0009613350-2023-00350
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    June 19, 2023
    Report Date
    December 19, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED: D2; D4(UDI); G4: PRODUCT IS NOT CLEARED IN US BUT IS SIMILAR TO K192236. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED INITIAL IMAGING DEMONSTRATING LOOSENING OF THE LEFT FEMORAL IMPLANT WITH SUBSEQUENT REVISION AND NORMAL APPEARANCE. SUBSEQUENT IMAGING DEMONSTRATES A NON-DISPLACED LATERAL CORTICAL FRACTURE AND EXTENSIVE LUCENCY ALONG THE FEMORAL IMPLANT WITH PROBABLE LOOSENING. THE DISTAL AND PROXIMAL REVITAN STEMS WERE RECEIVED WITH THE COCR HEAD MOUNTED ON THE PROXIMAL STEM AND THE CONICAL NUT DISASSEMBLED. THE DISTAL AND PROXIMAL STEMS SHOW DAMAGES FROM THE REVISION SURGERY IN THE FORM OF SCRATCHES AND NICKS. NO BONE INGROWTH CAN BE SEEN ON THE ANCHORING SURFACE OF THE PROXIMAL STEM. FURTHER, ESPECIALLY MEDIALLY AND ON THE LATERAL SURFACE POLISHED AREAS CAN BE FOUND. ON THE ANCHORING SURFACE OF THE DISTAL STEM LITTLE BONE ATTACHMENTS CAN BE FOUND. THE DISTAL TIP HAS MULTIPLE NICKS, ESPECIALLY ON THE LATERAL SIDE, MOST LIKELY FROM THE REMOVAL PROCESS DURING THE REVISION SURGERY. THE CONNECTION PIN OF THE DISTAL STEM IS FRACTURED IN THE NON-BLASTED AREA AND THE PROXIMAL PART OF THE CONNECTION PIN IS STILL ASSEMBLED TO THE PROXIMAL PART OF THE STEM. TWO AREAS CAN BE SEEN ON THE FRACTURE SURFACES, ONE WITH A VERY FINE STRUCTURE AND ONE WITH A COARSER STRUCTURE, WHICH POINTS TO A FATIGUE FRACTURE. THE BLACKISH DISCOLORATION VISIBLE ON THE FRACTURE SURFACES CAN MOST LIKELY BE ATTRIBUTED TO OXIDATION PROCESSES. ON THE PROXIMAL FRACTURE PART OF THE CONNECTION PIN, SURFACE CHANGES ADJACENT TO THE FRACTURE SURFACE CAN BE FOUND, ESPECIALLY ANTEROLATERAL. CLOSER INSPECTION OF THESE CHANGES WITH A LOW POWER MICROSCOPE REVEALED POLISHING, SMEARED MATERIAL, FRETTING AND CORROSION. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. WITH THE INFORMATION PROVIDED, WE ARE UNABLE TO PROVIDE FURTHER ANALYSIS OF THE COMPLAINT REPORTED OR DRAW ANY DEFINITIVE CONCLUSIONS AS TO THE ROOT CAUSE OF THE REPORTED ISSUE. A SUMMARY OF THE INVESTIGATION AS BEEN PROVIDED TO THE CUSTOMER. 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 · 0

    (B)(4). G2 ¿ FOREIGN ¿ GERMANY. D10- REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 105, TAPER 12/14, ITEM # 0100402105, LOT#2737723. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. A FOLLOWUP/FINAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION. BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY SURGERY AND APPROXIMATELY 9 YEAR LATER A REVISION SURGERY WAS PERFORMED DUE TO THE IMPLANT FRACTURE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144259 REVITAN, DISTAL PART, CURVED, UNCEMENTED, 24/200 PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR KWY ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2706028
    982818 REVITAN, DISTAL PART, CURVED, UNCEMENTED, 24/200 PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR KWY ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2706028

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Hospitalization| R SEE H10 NARRATIVE.