BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 20/140

    MDR report key: 18159626 · Received November 17, 2023

    Report

    Report Number
    0009613350-2023-00636
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    November 6, 2023
    Report Date
    May 1, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWY
    UDI-DI
    00889024592933
    PMA / PMN Number
    K192236
    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

    HIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: REVITAN®, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 65, TAPER 12/14 ITEM NUMBER 0100402065 LOT 2799951. DURAL ALPHA INSERT W RIM OO/32 ITEM NUMBER 0100013515 LOT 2602123. SULOX-HD 32 L 12/14 ITEM NUMBER 173207 LOT 2803430. ALLOFT-S ALLOCLASSIC SHL 64/OO ITEM NUMBER 4271 LOT #2781144. THE REVITAN STEM WAS RETURNED FOR INVESTIGATION AND THE CONNECTION PIN OF THE DISTAL STEM IS FRACTURED. THE SULOX HEAD IS STILL MOUNTED ON THE TAPER OF THE PROXIMAL PART. THE SULOX HEAD SHOWS SOME METAL TRANSFER ON THE SURFACE, BUT IT IS OVERALL INCONSPICUOUS. NO BONE ONGROWTH CAN BE SEEN ON THE ANCHORING SURFACE OF THE PROXIMAL PART. ON THE MEDIAL AND LATERAL SIDES, POLISHED AREAS ARE VISIBLE, INDICATING POSSIBLE LOOSENING AND MOVEMENT AGAINST THE BONE. ON THE ANTERIOR AND POSTERIOR SIDE AS WELL AS ON THE NECK OF THE TAPER, SOME SCRATCHES ARE VISIBLE, MOST LIKELY DUE TO REVISION SURGERY. THE CHARACTERISTICS ON THE FRACTURE SURFACES POINT TO A FATIGUE FRACTURE WITH THE ORIGIN LOCATED ON THE LATERAL SIDE. SIGNS OF BONE ATTACHMENTS CAN BE FOUND ON THE MOST DISTAL AREA OF THE DISTAL PART. THE LATERAL AND ANTERIOR SIDES SHOW DAMAGE FROM REVISION SURGERY. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND THE PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY ON UNKNOWN DATE WITH UNKNOWN PRODUCT DUE TO UNKNOWN REASON. AFTER THAT IN 2015 THE PATIENT HAD A FIRST REVISION DUE TO INFECTION AND ZIMMER BIOMET PRODUCTS WERE PLACED. SUBSEQUENTLY, EIGHT (8) YEARS AFTER IMPLANTATION THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO IMPLANT FRACTURE. DURING THE REVISION IMPLANT FRACTURE CONFIRMED. NOTED ADHESIONS, BONY INGROWTH IN DISTAL STEM AND CERCLAGE WIRES, AND METALLOTIC SYNOVITIS. THE STEM, TAPER, AND HEAD WERE EXCHANGED WITH COMPETITOR COMPONENTS AND A ZB LINER PLACED WITHOUT COMPLICATIONS. AN AP OVERVIEW OF THE PELVIS TAKEN BEFORE SECOND REVISION SURGERY WAS PROVIDED AND SHOWS IMPLANT FRACTURE AT THE CONNECTION PIN BETWEEN THE DISTAL AND PROXIMAL PART. BASED ON THE INVESTIGATION, A FRACTURE OF THE CONNECTION PIN OF THE REVITAN STEM CAN BE CONFIRMED. THE CHARACTERISTICS OF THE FRACTURE SURFACES POINT TO A FATIGUE FRACTURE. THE CAUSE MAY BE MULTIFACTORIAL, CONSISTING OF PATIENT- AND PROCEDURE-RELATED FACTORS. NEVERTHELESS, WITH THE INFORMATION PROVIDED, WE ARE UNABLE TO PROVIDE ANY DEFINITIVE CONCLUSIONS AS TO THE ROOT CAUSE OF THE REPORTED ISSUE. 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

    (B)(4). D10: REVITAN®, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 65, TAPER 12/14 ITEM NUMBER 0100402065 LOT UNKNOWN. G2: FOREIGN: GERMANY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: REVITAN®, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 65, TAPER 12/14 ITEM NUMBER 0100402065 LOT 2799951. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD A REVISION SURGERY DUE TO IMPLANT FRACTURE. DURING THE REVISION IMPLANT FRACTURE CONFIRMED, NOTED ADHESIONS, BONY INGROWTH IN DISTAL STEM AND CERCLAGE WIRES, AND METALLOTIC SYNOVITIS. THE STEM, TAPER, AND HEAD WERE EXCHANGED WITH COMPETITOR COMPONENTS AND A ZIMMER BIOMET LINER WAS PLACED WITHOUT COMPLICATIONS. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY DUE TO BROKEN REVITAN STEM. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321246 REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 20/140 HIP IMPLANT KWY ZIMMER GMBH N/A 2786473 00889024592933

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H10 NARRATIVE.| SEE H11 NARRATIVE.