BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO RADIAL STEM 6.0X40MM

    MDR report key: 6969751 · Received October 23, 2017

    Report

    Report Number
    0001825034-2017-09572
    Event Type
    Injury
    Date Received
    October 23, 2017
    Date of Event
    September 26, 2014
    Report Date
    March 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWJ
    PMA / PMN Number
    PK042032
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS- COBALT HV BONE CEMENT 40G, CATALOGUE# 402282, LOT# 979340. RECEIVED AND REVIEWED PRIMARY SURGICAL OPERATIVE NOTES. THE PREOP/POSTOP DIAGNOSIS WAS RIGHT WRIST OSTEOARTHRITIS AND RIGHT WRIST SCAPHOLUNATE ADVANCED COLLAPSE. THE PROCEDURE INCLUDED A RIGHT ARTHROPLASTY, PROXIMAL ROW CARPECTOMY AND POSTERIOR INTEROSSEOUS NERVE NEURECTOMY. WITH REGARDS TO SIZING, THE SURGEON TRIALED THE CAPITATE PLATE WITH A 6MM AUGMENT WHICH WAS TOO LARGE. THE SURGEON THEN WENT TO THE SMALLEST CARPAL HEAD WHICH SEEMED TO FIT WELL; HOWEVER, HE DID HAVE TO TRIM THE CAPTIVATE HEAD WITH AN OSCILLATING SAW AS WELL AS REMOVE A SMALL PORTION OF THE TRAPEZOID IN ORDER TO HAVE THE PLATE FIT FLUSH. ON THE RADIAL SIDE, THE SURGEON REAMED FOR A 26MM. THE TRIAL IMPLANT WAS PLACED AND FOUND TO BE PROUD. THE SURGEON RECUT APPROXIMATELY 3MM MORE IN ORDER TO SEAT THE TRIAL. ALL TRIALS WERE THEN PLACED AND FOUND TO REPRODUCE ANATOMY WELL ALLOWING APPROXIMATELY 2MM OF DISTRACTION. THE FINAL IMPLANTS WERE PLACED AND FOUND TO BE SATISFACTORY. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE PER THE SURGEON. ROOT CAUSE REMAINS UNDETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: 180320, MAESTRO TC CAPITATESTEM, 091780, 180151, MAESTRO RAD W/BRG 7X15 7.5 RT, 002440, 180350, VARIABLE LOCK SCREW 4.75X15MM, 551350, 180354, VARIABLE LOCK SCREW 4.75X35MM, 551310, 180363, MAESTRO TC CARPALHD 7X15MM STD, 457600, 180395, MAESTRO TC CARPAL PLATE 9X37MM, 605040. CUSTOMER HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 09573.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    IT WAS REPORTED BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT WRIST ARTHROPLASTY. SUBSEQUENTLY, IT IS ALLEGED THAT THE PATIENT IS EXPERIENCING TINGLING, BURNING, AND PAIN IN HER FINGERS, A PAINFUL LUMP IN HER WRIST, AND LOOSENING. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT WRIST ARTHROPLASTY. SUBSEQUENTLY, IT IS ALLEGED THAT THE PATIENT IS EXPERIENCING TINGLING, BURNING, AND PAIN IN HER FINGERS, A PAINFUL LUMP IN HER WRIST, LOOSENING, AS WELL AS NERVE/ TENDON IRRITATION FROM THE PROSTHESIS BEING TOO LARGE FOR THE PATIENT. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748956 MAESTRO RADIAL STEM 6.0X40MM PROSTHESIS, WRIST JWJ ZIMMER BIOMET, INC. N/A 172020

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O SEE H10 NARRATIVE