BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN HEAD

    MDR report key: 19861059 · Received July 30, 2024

    Report

    Report Number
    0009613350-2024-00316
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    November 23, 2023
    Report Date
    September 6, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2 REPORT SOURCE : FOREIGN: SWITZERLAND. LITERATURE : JANA F. SCHADER, CAROLINE THALMANN1, KATHARINA S. MAIER,TOM SCHIENER, KARL STOFEL2,3 & ARNO FRIGG (2023) PROSPECTIVE EVALUATION OF CLINICAL AND RADIOGRAPHIC 10-YEAR RESULTS OF FITMORE SHORT-STEM TOTAL HIP ARTHROPLASTY. JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH. (1-6). HTTPS://DOI.ORG/10.1186/S13018-023-04359-3. D10: UNKNOWN LINER UNKNOWN ITEM# AND LOT #. UNKNOWN FITMORE STEM UNKNOWN ITEM# AND LOT #. UNKNOWN CUP UNKNOWN ITEM# AND LOT #. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H3: PRODUCT INFORMATION IS UNKNOWN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS 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. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: B5; G3; H2; H3; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS 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. THE AUTHOR OF THE STUDY CLAIMS THAT THERE WAS NO TRAUMA; THE DISLOCATION WAS MOST LIKELY CAUSED BY POSTOPERATIVE SOFT TISSUE LAXITY. FOLLOW UP RESPONSE INDICATED THAT THE PATIENT DISLOCATED THE DAY AFTER INITIAL SURGERY DUE TO POSTOPERATIVE JOINT LAXITY. DURING A TOTAL HIP, THE LOWER EXTREMITY AND JOINT SOFT TISSUES ARE STRETCHED, PULLED, TWISTED, AND FLEXED IN MULTIPLE WAYS TO GAIN ACCESS FOR IMPLANTATION. AFTER THE FINAL IMPLANTS ARE IN PLACE, A FINAL RANGE OF MOTION CHECK IS PERFORMED TO VERIFY SIZE, COMPATIBILITY, AND STABILITY OF THE IMPLANTS. HOWEVER, THE PROCEDURE IS CARRIED OUT UNDER GENERAL AND/OR SPINAL ANESTHESIA WHICH FURTHER RELAXES THE SOFT TISSUES OF THE HIP, PREDISPOSING THE JOINT TO INSTABILITY. THE PATIENT IS THEN AT INCREASED RISK FOR DISLOCATION UNTIL THE ANESTHESIA AND ADDITIONAL PAIN MEDICATIONS ARE FULLY METABOLIZED AND THE SOFT TISSUES ARE STRENGTHENED WITH WEIGHTBEARING EXERCISE. THE COMPLAINT INDICATES THAT A POSTOPERATIVE DISLOCATION OCCURRED WITH POSTOPERATIVE LIGAMENT LAXITY BEING A CONTRIBUTING FACTOR. BASED ON THE NEW AVAILABLE INFORMATION, IT CAN THEREFORE BE ASSUMED THAT THE DISLOCATION WAS MOST LIKELY CAUSED BY POSTOPERATIVE SOFT TISSUE LAXITY. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT 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 IN A JOURNAL ARTICLE THAT ONE PATIENT DISLOCATED POST-OPERATIVE DAY 1 AND WAS TREATED WITH CLOSED REDUCTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE PATIENT DISLOCATED POST-OPERATIVE DAY 1 AND WAS TREATED WITH CLOSED REDUCTION. THE AUTHOR INDICATES THAT THE PATIENT SUSTAINED A DISLOCATION DUE TO POSTOP SOFT TISSUE LAXITY. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240824 UNKNOWN HEAD HIP PROTHESIS LZO ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE.