BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL HEAD

    MDR report key: 9288381 · Received November 6, 2019

    Report

    Report Number
    0002648920-2019-00818
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    May 9, 2017
    Report Date
    February 25, 2020
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING POSTOP DIAGNOSIS OF A FAILED RIGHT HIP WITH INSTABILITY, PAIN, LIMP, LIKELY ALTR FROM COBALT TOXICITY WITH ASSOCIATED GLUTEUS MEDIUS TENDON TEAR/NECROSIS. FIVE RECENT DISLOCATIONS WERE NOTED, 2 POSTERIOR AND 3 ANTERIOR. INTERVAL BETWEEN MEDIUS AND TFL QUITE SCARRED. NECROTIC HIP CAPSULE NOTED, LARGE AMOUNT OF YELLOW FLUID EXPRESSED. LARGE AMOUNT OF DENUDED FEMORAL CALCAR PROXIMALLY. CHARACTERISTIC BLACK SIGNS OF CORROSION ON THE NECK WERE EVIDENT. THE LOCKING MECHANISM NOTED TO BE FIXED AND COULD NOT BE MOVED. SHELL WAS WELL-FIXED AND IN GOOD POSITION WITH SOME LOSS OF SOFT TISSUE AND BONE POSTERIOR SUPERIORLY. MARGINALLY VIABLE CAPSULE LEFT FOR REPAIR, GLUTEUS MEDIUS HAD BEEN NOTED TO BE TORN FROM THE NECROTIC APPEARING BONE ON THE GREATER TROCHANTER NEAR COMPLETE TEAR WITH VIABLE MUSCLE BUT MARGINALLY VIABLE BONE. DHR WAS REVIEWED AND DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT 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

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: REF 00620205622, LOT 61729020, TM SHELL 56MM. REF 00631005632, LOT 61655223, LONGEVITY LINER. REF 00771101210, LOT 61719232, M/L TAPER STEM 12.5. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0002648920-2019-00814, 0001822565-2019-04772, 0001822565-2019-04294-1. CUSTOMER HAS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO INSTABILITY, PAIN, LIMP, RECURRENT DISLOCATIONS, AND ELEVATED METAL ION LEVELS. DURING THE REVISION PROCEDURE, EXTENSIVE TISSUE DAMAGE, CALCAR EROSION, AND NECROSIS WAS NOTED WITH ASSOCIATED TENDON TEAR. CORROSION WAS NOTED ABOUT THE HEAD AND NECK TRUNNION. THE HEAD AND LINER WERE EXCHANGED WITHOUT COMPLICATION, AND THE TENDON TEAR WAS REPAIRED WITH A SUTURE ANCHOR. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079223 COCR FEMORAL HEAD PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 61350077

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R