BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 20/140

    MDR report key: 16938490 · Received May 16, 2023

    Report

    Report Number
    0009613350-2023-00214
    Event Type
    Injury
    Date Received
    May 16, 2023
    Date of Event
    April 14, 2023
    Report Date
    June 19, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWZ
    UDI-DI
    00889024593022
    PMA / PMN 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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D2 D4, D9, D10, G1, G3, G6, H1, H2, H3, H4, H6, H10. D10: ASSOCIATED PRODUCTS: ITEM NUMBER: 00-8775-036-02, ITEM NAME: BIOLOX DELTA HEAD 12/14 36X0 LOT: 3013366. THE FRACTURED REVITAN STEM WAS RETURNED WITH THE BIOLOX HEAD MOUNTED ON THE TAPER. THE BIOLOX HEAD SHOWS METALLIC SMEARING BOTH ON THE ARTICULATING SURFACE AND ON THE NON-ARTICULATING SURFACE. THE DISTAL AND PROXIMAL PARTS OF THE REVITAN STEM SHOW DAMAGES FROM THE REVISION SURGERY IN THE FORM OF SCRATCHES, NICKS AND AREAS WHERE THE MATERIAL IS DEFORMED. THE NECK OF THE PROXIMAL PART SHOWS POLISHED AREAS, PARTICULARLY ON THE MEDIAL SIDE. AS IT IS POSSIBLE TO SEE ON THE RECEIVED X-RAY IMAGES, THESE POLISHED AREAS ARE MOST LIKELY DUE TO THE CONTACT OF THE NECK WITH THE MOST PROXIMAL CERCLAGE WIRE. NO BONE ONGROWTH CAN BE SEEN ON THE ANCHORING SURFACE OF THE PROXIMAL COMPONENT. BONE ATTACHMENT CAN BE FOUND ON THE ANCHORING SURFACES OF THE DISTAL COMPONENT. THE CONNECTION PIN OF THE DISTAL COMPONENT IS FRACTURED AND THE PATTERNS ON THE SURFACES POINT TO A FATIGUE FRACTURE WITH THE ORIGIN LOCATED ON THE LATERAL SIDE. THE LOCKING SCREW APPEARS TO BE INCONSPICUOUS. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE RECEIVED AND REVIEW BY A HEALTH CARE PROFESSIONAL. THE PATIENT IS MALE AND WAS BORN IN 1958. THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2001 AND A FIRST REVISION SURGERY ON (B)(6) 2020 DUE TO STEM LOOSENING. THE SURGICAL NOTES OF THIS PROCEDURE REPORT EXTENSIVE SCAR TISSUE AND OSSIFICATION IN THE HIP JOINT AS WELL AS AN ALMOST COMPLETE RUPTURE OF THE PSOAS TENDON. SUBSEQUENTLY, ON (B)(6) 2023 THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH PRESSURE IN THE LEFT GROIN, PAIN, GAIT UNSTEADINESS AND DIFFICULTY WALKING. THE PATIENT WAS UNABLE TO BEAR WEIGHT AND HAD SWELLING OVER THE GROIN AND PROXIMAL FEMUR. RADIOGRAPHIC IMAGING DISPLAYED FRACTURE OF THE STEM AT THE LEVEL OF THE LESSER TROCHANTER AND TWO FRACTURED CERCLAGE WIRES. ON (B)(6), 2023 THE PATIENT UNDERWENT A SECOND REVISION SURGERY. THE SURGICAL NOTES OF THIS PROCEDURE CONFIRMED THE FRACTURE OF THE DISTAL STEM AND CERCLAGE WIRES. ALL COMPONENTS, EXCEPT FOR THE CUP AND INLAY, WERE REVISED. OF NOTE, DURING THE PROCEDURE, THE FRACTURED PROXIMAL STEM WAS REMOVED WITHOUT DIFFICULTY AND THE DISTAL PORTION OF THE FRACTURED STEM REQUIRED ADDITIONAL EFFORT DUE TO OSTEOINTEGRATION. THE DISTAL FRACTURED STEM WAS GRADUALLY LOOSENED WITH KIRSCHNER WIRES AND VARIOUS CHISELS, LEADING TO A DISTAL SPLIT OF THE FEMUR, DESPITE PLACEMENT OF A SAFETY CERCLAGE. DURING THE COURSE OF CHISELING, THE DORSAL FEMUR ALSO FRACTURED AT THE LEVEL OF THE OSTEOTOMY. A TOTAL OF 6 RADIOGRAPHS WERE RECEIVED AND REVIEW BY A RADIOLOGIST. ONE AP PELVIS AND SINGLE VIEW OF THE LEFT HIP TAKEN ON (B)(6), 2020, BEFORE THE FIRST REVISION SURGERY. THREE AP PELVIS AND SINGLE VIEWS OF THE LEFT HIP TAKEN ON (B)(6), 2020, AFTER THE FIRST REVISION SURGERY. ONE AP PELVIS AND SINGLE VIEW TAKEN ON (B)(6), 2023, BEFORE SECOND REVISION SURGERY. ONE AP PELVIS AND SINGLE VIEW TAKEN ON (B)(6), 2023, AFTER SECOND REVISION SURGERY. IN THE RADIOGRAPHS TAKEN AFTER THE FIRST REVISION SURGERY IT IS POSSIBLE TO SEE THE IMPLANTED DISTAL AND PROXIMAL PARTS OF THE REVITAN STEM AND THREE CERCLAGE WIRES. PERSISTENT RADIOLUCENCY CAN BE SEEN ALONG THE PROXIMAL FEMORAL COMPONENT. IN THE RADIOGRAPHS TAKEN BEFORE THE SECOND REVISION SURGERY IT IS POSSIBLE TO SEE A FRACTURE OF THE LEFT FEMORAL COMPONENT AT THE JUNCTION OF THE PROXIMAL FEMORAL STEM AND FRACTURED CERCLAGE WIRES. THE RADIOGRAPH TAKEN BEFORE FIRST REVISION SURGERY AND THE RADIOGRAPH TAKEN AFTER SECOND REVISION SURGERY WERE REVIEWED AND ASSESSED, HOWEVER THEY DO NOT PROVIDE ADDITIONAL INFORMATION TO THE INVESTIGATION. THE RADIOLUCENCY SHOWN IN THE X-RAYS TAKEN AFTER THE FIRST REVISION SURGERY SUGGESTS A POSSIBLE LACK OF PROXIMAL BONE SUPPORT. BASED ON THE LITERATURE, THE LACK OF PROXIMAL BONE SUPPORT FOR THE STEM INCREASES THE MECHANICAL STRESSES ON THE TAPER AND THUS INCREASES THE RISK FOR STEM FRACTURE. OTHER FACTORS SUCH AS PATIENT AGE, MEDICAL HISTORY, BMI AND ACTIVITY LEVEL, MAY HAVE LED OR CONTRIBUTED TO THE REPORTED EVENT. IN CONCLUSION, BASED ON THE INVESTIGATION A PIN FRACTURE OF THE DISTAL REVITAN STEM CAN BE CONFIRMED AND MOST LIKELY ATTRIBUTED TO FATIGUE. NEVERTHELESS, SINCE THE CAUSE MAY BE MULTIFACTORIAL, CONSISTING OF PATIENT- AND PROCEDURE-RELATED FACTORS, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. 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: MEDICAL DEVICES: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 75, TAPER 12/14; ITEM# 01.00402.075; LOT# UNKNOWN. G2: FOREIGN: SWITZERLAND. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT SIDED HIP REVISION SURGERY 3 YEARS AFTER THE INITIAL IMPLANTATION DUE TO A FRACTURE OF THE IMPLANT. 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
    2184344 REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 20/140 HIP PROSTHESIS KWZ ZIMMER SWITZERLAND MANUFACTURING GMBH 2827546 00889024593022

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization| R SEE H10| SEE H10 NARRATIVE