BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL HEAD 12/14 TAPER

    MDR report key: 9895055 · Received March 29, 2020

    Report

    Report Number
    0002648920-2020-00197
    Event Type
    Malfunction
    Date Received
    March 29, 2020
    Date of Event
    March 3, 2020
    Report Date
    August 4, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B1; D4; D11; H1; H2; H3; H6. D11: BIOMET ACT ARTIC E1 HIP BRG 28X44MM CAT#EP-200150 LOT#885270 BIOMET G7 DUAL MOBILITY LINER 44MM F CAT#110024464 LOT#776200 BIOMET G7 SUCTION CUP STERILE CAT#110010571 LOT#UNK BIOMET G7 OSSEOTI 4 HOLE SHELL 54MM F CAT#110010245 LOT#6683084 ZIMMER FEMORAL STEM FIBER METAL MIDCOAT COLLARED CEMENTLESS 12/14 NECK TAPER STANDARD NECK OFFSET SIZE 15 STANDARD BODY 15 MM DISTAL STEM DIAMETER 160 MM STEM. CAT#00784101500 LOT#64311861 REPORTED EVENT WAS CONFIRMED WITH MEDICAL RECORDS PROVIDED. AN IMAGE OF THE EXPLANTED HEAD AND ACTIVE ARTICULATION BEARING WAS PROVIDED. VISUAL EXAMINATION IDENTIFIED NO DAMAGES. NO FURTHER EVALUATION COULD BE PERFORMED WITH THE IMAGE PROVIDED. MEDICAL RECORDS AND RADIOGRAPHS WERE PROVIDED AND REVIEWED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT DISLOCATED WHILE TWISTING TO LOOK AT THE CHAIR. A CLOSED REDUCTION WAS PERFORMED BUT ONLY THE HEAD WAS IN THE CUP. THEREFORE, AN OPEN REDUCTION WAS PERFORMED. THE ACTIVE ARTICULATION BEARING WAS FOUND TO HAVE DISASSOCIATED FROM THE HEAD. HEMATOMA WAS DEBRIDED. THE HEAD AND BEARING WERE REMOVED, REASSEMBLED, AND IMPLANTED. NO OTHER COMPLICATIONS/ FINDINGS WERE NOTED. REVIEW OF THE RADIOGRAPHS IDENTIFIED THE FOLLOWING: RIGHT HIP ARTHROPLASTY DISLOCATION WITH SUBSEQUENT REDUCTION AND ECCENTRIC ALIGNMENT AS NOTED CONSISTENT WITH THE REPORTED LINER PLACEMENT. NO FURTHER EVALUATION COULD BE PERFORMED WITH THE IMAGES PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET LINER CAT# 110024464 LOT#7 76200. BIOMET BEARING CAT# EP-200150 LOT# 875270. UNKNOWN CUP. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT HIP ARTHROPLASTY. APPROXIMATELY 2 WEEKS LATER PATIENT WENT TO SIT DOWN AND TWISTED BACK AND FELT A POP. THE PATIENT WAS REDUCED, BUT IT WAS JUST THE METAL HEAD IN THE CUP SANS POLY. WHEN THE SURGEON OPENED HIM UP, THE POLY WAS DISASSOCIATED FROM THE FEMORAL HEAD. THE SURGEON FELT THE IMPLANTS WERE ACCEPTABLE. THE IMPLANTS WERE REASSEMBLED AND THE HIP REDUCED. 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
    359650 FEMORAL HEAD 12/14 TAPER PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 64482573

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R