BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER

    MDR report key: 8925203 · Received August 23, 2019

    Report

    Report Number
    0002648920-2019-00632
    Event Type
    Injury
    Date Received
    August 23, 2019
    Date of Event
    July 2, 2018
    Report Date
    January 6, 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
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING HISTORY OF A LEFT FEMORAL NECK FRACTURE. PATIENT WAS EXPERIENCING REDNESS AND DRAINAGE FROM THE SURGICAL SITE AND UNDERWENT A REVISION FOR RECURRENT DISLOCATION. THE JOINT WAS EXTREMELY UNSTABLE BECAUSE OF IMPINGEMENT. A HEMATOMA ABOUT 100 ML WAS DRAINED BELOW THE BURSA AND THE ENTIRE POSTERIOR CAPSULE WAS NON-EXISTENT. DHR 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DOB: 1962 (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART: 00811400100, FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH, LOT: 63735436; PART: 00801802230, FEMORAL HEAD 12/14 TAPER, LOT: 63677745; PART: P0463048, AVAN CMNTD SHELL SS 48MM, LOT: 0001105980; PART: P0560048, AVAN INSERT 48/22, LOT: 0001102705; PART: 4711500396-1, OPTIPAC-S 60 REFOB BN CMT R, LOT: B708C05355; PART: 4711500693-1, OPTIPAC-S 60 REFOB BN CMT R, LOT: A710B05615. FOREIGN SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920-2019-00631, 0002648920-2019-00632.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY, SUBSEQUENTLY THE PATIENT WAS REVISED SEVEN MONTHS LATER DUE TO RECURRENT DISLOCATIONS, INSTABILITY, AND IMPINGEMENT. DURING THE REVISION A HEMATOMA WAS NOTED AS WELL AS AN ABSENT POSTERIOR JOINT CAPSULE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718592 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 63677745

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R