BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 MP TYPE1 BM HO 15.0

    MDR report key: 15084197 · Received July 22, 2022

    Report

    Report Number
    0001825034-2022-01674
    Event Type
    Injury
    Date Received
    July 22, 2022
    Date of Event
    June 30, 2022
    Report Date
    August 16, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDB
    UDI-DI
    00880304513181
    PMA / PMN Number
    NI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SOURCE FOREIGN: AUSTRALIA . MEDICAL PRODUCTS: UNKNOWN-UNKNOWN FEMORAL HEAD-UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01676. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, REQUESTED BUT NOT RETURNED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6 COMPONENT CODE: MECHANICAL (G04) STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED; IT WAS MENTIONED THAT THE SURGEON MAY HAVE MISJUDGED WHICH STEM TO USE HOWEVER WITHOUT MEDICAL RECORDS THIS CANNOT BE CONFIRMED. 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCT 650-1163-DELTA CER FEM HD 32/-3MM T1-3066357 010000927-G7 HI-WALL E1 LINER 32MM E-7046529 110010244-G7 OSSEOTI 3 HOLE SHELL 52MM E-7213837 51-116120-TPRLC 133 MP TYPE1 BM SO 12.0-6763121 THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION SURGERY 1-DAY POST IMPLANTATION DUE TO DISLOCATING. SURGEON BELIEVED THAT THE REASON OF THE DISLOCATION WAS INAPPROPRIATE HORIZONTAL OFFSET AND HE WAS ABLE TO RECTIFY THIS BY CHANGING THE STEM FROM HO TO A STD OFFSET TAPERLOC. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 1-DAY POST IMPLANTATION DUE TO INSTABILITY. THE SURGEON BELIEVES HE MISJUDGED THE HORIZONTAL OFFSET REQUIRED FOR THE PATIENT AND REVISED THE HO STEM TO STD STEM AND IN TURN REDUCING THE HORIZONTAL OFFSET AND THIS MADE THE PATIENT STABLE. 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
    611270 TPRLC 133 MP TYPE1 BM HO 15.0 PROSTHESIS, HIP JDB ZIMMER BIOMET, INC. N/A 6002168 00880304513181

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention| H SEE H10 NARRATIVE.| SEE H10 NARRATIVE.