BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DURASUL LINER

    MDR report key: 22495724 · Received July 14, 2025

    Report

    Report Number
    0009613350-2025-00564
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    June 3, 2025
    Report Date
    September 9, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. UNKNOWN SHELL ITEM# UNKNOWN LOT# UNKNOWN. UNKNOWN HEAD ITEM# UNKNOWN LOT# UNKNOWN. UNKNOWN STEM ITEM# UNKNOWN LOT# UNKNOWN. G2. REPORT SOURCE: 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. THE FOLLOWING SECTIONS WERE UPDATED: A2, A4, B3, B4, B5, B7, D1, D6A, D6B, D10, E1 - LAST NAME, G3, G6, H2, H6, H11. D10. ALLOFIT® ALLOCLASSIC®, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 58/LL ITEM# 4248 LOT# 3230118. DELTA CER FM HD 036/+4MM 12/14 ITEM# 650-0838 LOT# 3231317. MICRO TAPRLC LAT PC 17.5 12/14 ITEM# 650-0979 LOT# 7743997. DURASUL®, ALPHA INSERT, LL/36 ITEM# 0100013712 LOT# 3226932.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED DUE TO MISSING REFERENCE AND LOT NUMBERS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED THE FOLLOWING: AN ANTEROLATERAL APPROACH WITH FEMORAL HEAD REMOVAL AND 45° OSTEOTOMY REVEALED DEFORMITY WITHOUT CARTILAGE. AN ALLOFIT CUP WITH INLAY WAS INSERTED, BUT THE INLAY ONLY STUCK AFTER SEVERAL ATTEMPTS AND DISLOCATION OF THE INLAY. THE INLAY WAS CHANGED TO ONE OF THE SAME SIZE, WHICH STUCK IN AFTER THE SECOND ATTEMPT, AND DURING RENEWED REDUCTION DISLOCATION OCCURRED WITH EXTERNAL ROTATION. STABILITY WAS ACHIEVED USING A LATERALIZED NECK AND L-HEAD, WITH SLIGHT LEG LENGTHENING ACCEPTED. A SIZE 17.5 LATERALIZED MICROPLASTY SHAFT WITH A DEFINITIVE CERAMIC HEAD WAS IMPLANTED, SHOWING GOOD FIXATION AND NO FURTHER DISLOCATION TENDENCY. THE WOUND WAS RINSED AND CLOSED WITH STAPLES. NO COMPLICATIONS OCCURRED. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. AS THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AND NO PICTURES WERE PROVIDED, NO STATEMENT REGARDING THE CONDITION OF THE DEVICE CAN BE MADE AND A DEFINITIVE ROOT CAUSE COULD BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL HIP PROCEDURE, THE SURGEON HAS INTRAOPERATIVELY PROBLEMS TO INSERT THE INLAY CORRECTLY. A SECOND INLAY WAS USED TO COMPLETE THE PROCEDURE. DUE DILIGENCE IS IN PROCESS AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. INTRAOPERATIVELY THERE WERE INSERTION DIFFICULTIES WITH THE INLAY PLACEMENT AND THEN WITH REPOSITIONING, THE INLAY CONTINUED TO DISLOCATE. SUBSEQUENTLY, THE INLAY WAS REPLACED WITH ONE OF THE SAME SIZE AND SATISFACTORY TRIALING ALONG WITH DEFINITIVE PLACEMENT OF IMPLANTS WAS ABLE TO BE COMPLETED. UPON REDUCTION OPTIMAL ROM, STABILITY, AND NO DISLOCATION TENDENCY APPEARED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231736 UNKNOWN DURASUL LINER PROSTHESIS, HIP LZO ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male