BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTRAL LINER 36 MM I.D. SIZE KK FOR USE WITH 56 MM O.D. SIZE KK SHELL

    MDR report key: 6852015 · Received September 8, 2017

    Report

    Report Number
    0001822565-2017-06273
    Event Type
    Injury
    Date Received
    September 8, 2017
    Date of Event
    July 23, 2017
    Report Date
    December 28, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK120370
    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 · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: SHELL WITH CLUSTER HOLES POROUS 56 MM O.D. SIZE KK FOR USE WITH KK LINERS CAT: 00875705601 LOT: 63523572; BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5, TAPER 12/14 CAT: 00877503603 LOT: 2861623; BONE SCR 6.5X25 SELF-TAP CAT: 00625006525 LOT: 63059074; BONE SCR 6.5X20 SELF-TAP CAT: 00625006520 LOT: 62804930; FEMORAL STEM FIBER METAL TAPER COLLARLESS 12/14 NECK TAPER SIZE 14 STANDARD BODY STANDARD NECK OFFSET CAT: 00786201400 LOT: 61040362. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PROCODE: OQG. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CONCOMITANT MEDICAL PRODUCTS: UNK, UNKNOWN FEMORAL HEAD, UNK; UNK, UNKNOWN M/L TAPER STEM, UNK; UNK, UNKNOWN CONTINUUM CUP, UNK.

    Description of Event or Problem · 1

    IT WAS NOTED IN THE OPERATIVE NOTES THAT THE FEMORAL HEAD SHOWED LAXITY AND INSTABILITY. NO COMPLICATIONS OR DELAYS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO RECURRENT DISLOCATIONS. NO COMPLICATIONS OR DELAYS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630890 NEUTRAL LINER 36 MM I.D. SIZE KK FOR USE WITH 56 MM O.D. SIZE KK SHELL HIP PROSTHESIS KWA ZIMMER, INC. N/A 62954535

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R