BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD -3MM

    MDR report key: 9706649 · Received February 13, 2020

    Report

    Report Number
    0001825034-2020-00555
    Event Type
    Injury
    Date Received
    February 13, 2020
    Date of Event
    December 6, 2019
    Report Date
    May 12, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: (SUMMARIZED BY HCP) FINDINGS: 1 MONTH POSTOP VISIT : NO PAIN, FULL WEIGHT BEARING WITH NORMAL GAIT, HEALTH SCORE 76, SATISFIED LEFT HIP DISLOCATION, CORRECTED/RESOLVED IN THE ER SAME DAY ED VISIT NOTE PRESENTS TO ED WITH LEFT HIP DISLOCATION AND PAIN THAT OCCURRED WHILE DOING PHYSICAL THERAPY EXERCISES (SQUATTING), PATIENT HEARD POP PRIOR TO ONSET OF PAIN. CLOSED REDUCTION OF ANTERIOR DISLOCATION UNDER SEDATION PERFORMED IN THE ER, PATIENT DISCHARGED WITHOUT COMPLICATION NOTE: FRACTURE TREATMENT FORM USED BUT NO EVIDENCE OF FRACTURE FOUND. DISLOCATION ONLY. OFFICE VISIT OFFICE FOLLOW UP VISIT POST CLOSED REDUCTION GOOD ROM AND STABILITY, INCISION WELL HEALED, NV INTACT, XRAYS DEMONSTRATE WELL PLACED WELL FIXED REPLACEMENT, FOLLOW UP IN 4 MONTHS REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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: G7 NEUTRAL ARCOMXL LNR 36MM F, PN 010000741, LN 6500022, FEMORAL STEM PN: 51-104160 LN: 6143303, ACETABULAR SHELL PN: 010000664 LN: 6504029. MDR: 0001825034-2020-00554. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE 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 PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT EXPERIENCED A DISLOCATION AND PAIN REQUIRING A CLOSE REDUCTION APPROXIMATELY ONE MONTH LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171883 36MM COCR MOD HD -3MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 738670

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R