BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-T M/H RAD 2HL SHL 41/62MM

    MDR report key: 8374399 · Received February 27, 2019

    Report

    Report Number
    0001825034-2019-00857
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    April 15, 2004
    Report Date
    June 26, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: (SUMMARIZED BY HCP) INITIAL: DEGENERATIVE JOINT DISEASE SECONDARY TO CHILDHOOD HIP DISEASE, POSSIBLE AVN OF FEMORAL HEAD REAMED ACETABULUM FOR A 56MM COMPONENT, UNABLE TO PLACE 56MM DUE TO INADEQUATE BONE PURCHASE. CHANGED TO 62MM COMPONENT BUT DID NOT ALLOW FOR A SNUG FIT. 2 SCREWS PLACED FOR STABILITY. IT WAS A SLIGHT BIT VERTICAL, BUT THIS SEEMED TO BE APPROPRIATE. REDUCTION MANEUVER WAS PERFORMED AND IT WAS STABLE TO POSTERIOR DISLOCATION. IT WAS SLIGHTLY UNSTABLE TO ABDUCTION IN A LATERAL POSITION, BUT THIS SEEMED TO BE APPROPRIATE AT THIS TIME. HAD DIFFICULTY REDUCING THE FEMUR, TROCHANTERIC SLIDE PERFORMED USING A SAW. TROCHANTER WAS RETRACTED FORWARD. HEAD WAS PLACED AND A REDUCTION MANEUVER WAS PERFORMED. AT THAT TIME, WE NOTED TO GET SOME DISLOCATION LATERALLY, BUT IT WAS STABLE IN FULL FLEXION AND INTERNAL ROTATION. THOUGHT THAT THIS WOULD BE SATISFACTORY. 18G WIRE USED THROUGH BONE TUNNELS TO REATTACH THE GREATER TROCHANTER. WE NOTED TO GET SOME IMPINGEMENT OF THE GREATER TROCHANTER ON THE ACETABULAR COMPONENT. NO DISLOCATION COULD BE PERFORMED AT THIS TIME¿X-RAYS WERE NOT TOTALLY SATISFACTORY¿BUT FELT THAT THIS WAS AN APPROPRIATE ACETABULAR PLACEMENT. BLOOD LOSS OF 1000ML WAS NOTED. REVISION: AFTER POSTOPERATIVE X-RAYS IN RECOVERY, THE ACETABULAR COMPONENT WAS NOTED TO BE VERY VERTICAL. IT WAS FELT THAT ATTEMPT AT PLACING A 56MM CUP WITH A 38MM HEAD WOULD BE HELPFUL IN PREVENTING HER DISLOCATIONS. THE HIP WAS RANGED AND WE NOTED TO GET SOME IMPINGEMENT WITH HIP ABDUCTION, BUT WE WERE UNABLE TO BRING THE GREATER TROCHANTER DOWN ANY FURTHER SECONDARY TO ABDUCTOR TIGHTNESS. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES. A DEFINITIVE ROOT CAUSE CANNOT 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 162307 ¿ BI-METRIC STEM ¿ 966440; 11-163667 ¿ M2A MODULAR HEAD ¿ 335980; 15-105004 ¿ M2A TAPER LINER ¿ 963340. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED FOR THE INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION ON THE SAME DAY AS THE INITIAL IMPLANTATION DUE TO VERTICAL CUP ALIGNMENT. THE CUP AND HEAD COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167708 M2A-T M/H RAD 2HL SHL 41/62MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 846650

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R