BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 42X18X46 HUM HEAD

    MDR report key: 17081281 · Received June 7, 2023

    Report

    Report Number
    0001825034-2023-01294
    Event Type
    Injury
    Date Received
    June 7, 2023
    Date of Event
    November 11, 2021
    Report Date
    October 31, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    UDI-DI
    00880304212206
    PMA / PMN Number
    K060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: CATALOG #: PT-113950, PT HYBRID GLEN POST REGENEREX, LOT # 819030, CATALOG #: 113609, COMP PRIMARY STEM 9MM MICRO, LOT # 597750, CATALOG #: 113952, SM HYBRID GLENOID BASE 4MM, LOT # 241510, CATALOG #: 118001, VERSA-DIAL/COMP TI STD TAPER, LOT # 076870. H3: THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION OR NOT. ONCE THIS INFORMATION IS OBTAINED A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-04041, 0001825034-2021-00899, 0001825034-2023-01293 H3 OTHER TEXT : UNKNOWN IF PRODUCT WILL BE RETURNED.

    Additional Manufacturer Narrative · 0

    (B)(4). PROPOSED ANNEX G CODE: MECHANICAL (G04) - HEAD. THE REPORTED EVENT IS CONFIRMED THROUGH MEDICAL RECORDS AND MMI REVIEW. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: FRACTURED GLENOID COMPONENT (POROUS METAL GLENOID POST). REVISION TO REVERSE TOTAL SHOULDER INVOLVING BOTH HUMERAL AND GLENOID COMPONENTS COMPLETED, ALL STUDY COMPONENTS REMOVED. THERE WAS A LOT OF SCARRING AND OBLITERATION OF THE TISSUE PLANES FROM THE PREVIOUS SURGERY. THERE WAS METALLOSIS WITH DARK STAINING OF ALL THE SOFT TISSUES AND SYNOVIUM FROM METAL-ON METAL WEAR. THE GLENOID COMPONENT POLYETHYLENE FACE WAS LOOSE. THERE WAS A CYSTIC REACTION AROUND THE INFERIOR GLENOID WITH A LOT OF BLACKENED METAL WEAR DEBRIS, THE JOINT WAS METICULOUSLY DEBRIDED OF THIS. SHE DID HAVE A CYSTIC CONTAINED DEFECT FROM THE PREVIOUS PEG HOLES AS WELL AS A LARGE CYSTIC REACTION OF THE INFERIOR GLENOID THAT MEASURED 1.5CM. NEW DEFINITIVE COMPONENTS WERE IMPLANTED AND EXCELLENT STABILITY WAS ACHIEVED. PATIENT TO RECOVERY IN GOOD CONDITION WITH NO INTRA-OP COMPLICATIONS NOTED. REVIEW OF THE RADIOGRAPHS FOUND THE FOLLOWING: SUSPECTED LOOSENING, AND MILD OSTEOPENIA, GLENOID IMPLANT APPEARS FRACTURED AS WELL AS HUMERAL IMPLANT APPEARS LARGER THAN EXPECTED FOR PATIENTS ANATOMY. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED APPROXIMATELY 3 YEARS AGO. SUBSEQUENTLY, THE PATIENT REPORTED TO HER SURGEON THAT SHE HAD BEEN DOING FINE UNTIL SHE REACHED DOWN TO GRAB SOMETHING AND FELT A PAIN IN HER LEFT SHOULDER. FOLLOW UP RADIOLOGY CONFIRMED FRACTURE OF THE CENTRAL SCREW WITH SUBSEQUENT LOOSENING AND OSTEOLYSIS FROM DEBRIS GENERATION. THE PATIENT REPORTS SHE HAS SINCE HAD PAIN, DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, AND LIMITED RANGE OF MOTION. THE PATIENT WAS REVISED TO A REVERSE TOTAL SHOULDER APPROXIMATELY A YEAR AND A HALF AGO DUE TO GLENOID IMPLANT FRACTURE. DURING THE REVISION, EVIDENCE OF METALLOSIS AND WEAR WERE FOUND AS WELL AS CYSTIC DEFECTS AND SIGNIFICANT SCAR TISSUE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH UNKNOWN PRODUCT EXCEPT FOR SPECIFYING IMPLANTATION OF A BIOMET BASE PLATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME AND THE STUDY IS NOW COMPLETE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956887 VERSA-DIAL 42X18X46 HUM HEAD EXTREMITY IMPLANT HSD ZIMMER BIOMET, INC. N/A 437230 00880304212206

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R