BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR NC LAT 13X145

    MDR report key: 16387571 · Received February 16, 2023

    Report

    Report Number
    0001825034-2023-00339
    Event Type
    Injury
    Date Received
    February 16, 2023
    Date of Event
    January 25, 2023
    Report Date
    April 13, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS:¿ ITEM NUMBER: 11-173663 ITEM NAME: M2A 38MM MOD HD +3MM NK LOT NUMBER: 780870, ITEM NUMBER: 15-106056 ITEM NAME: M2A-38 CUP NON FLARED SZ 56MM LOT NUMBER: 949000, ITEM NUMBER: 31-323230 ITEM NAME: 3.2MMX30MM RNGLC+ ACET DRL BIT LOT NUMBER:355010, ITEM NUMBER: 00-510-400-00 ITEM NAME: EXODUS HIP STEM REMOVAL BLADES LOT NUMBER: 21021, ITEM NUMBER: 430060 ITEM NAME: RADIAL OSTEOTOME 6MM LOT NUMBER: 541312, ITEM NUMBER: 11-300818 ITEM NAME: ARCOS 18X150MM SPL TPR DIST LOT NUMBER: 381820, ITEM NUMBER: 11-301312 ITEM NAME: ARCOS CON SZ B HI 60MM LOT NUMBER: 838120, ITEM NUMBER: 11-302101 ITEM NAME: ARCOS TROCH CLAW LARGE 100MM LOT NUMBER: 506530, ITEM NUMBER: 11-302138 ITEM NAME: ARCOS LATERAL TROCH BOLT 38MM LOT NUMBER:240720, ITEM NUMBER: 650-1055 ITEM NAME: CER BIOLOXD OPTION HD 28MM LOT NUMBER: 3130999 , ITEM NUMBER: 650-1064 ITEM NAME: CER OPTION TYPE 1 TPR SLEVE -6 LOT NUMBER: 3100122, ITEM NUMBER: 110010268 ITEM NAME: G7 OSSEOTI MULTIHOLE 60MM G LOT NUMBER: 6833750, ITEM NUMBER: 110024465 ITEM NAME: G7 DUAL MOBILITY LINER 46MM G LOT NUMBER: 358140, ITEM NUMBER: 110031013 ITEM NAME: VIVACIT-E DM BEARING 28X46MM LOT NUMBER: 65254751, ITEM NUMBER: 00-6250-065-40 ITEM NAME: BONE SCREW 6.5X40 SELFTAP LOT NUMBER: J7250390, ITEM NUMBER: 00-6250-065-25 ITEM NAME: BONE SCREW 6.5X25 SELFTAP LOT NUMBER: J7280773, ITEM NUMBER: 00-6250-065-30 ITEM NAME: BONE SCREW 6.5X30 SELFTAP LOT NUMBER: 65514448, ITEM NUMBER: 65514448 ITEM NAME: BONE SCREW 6.5X30 SELFTAP LOT NUMBER: 65013422, ITEM NUMBER: 00-2232-004-18 ITEM NAME: CABLE-READY CABLE ASSY CERCLAGE COCR 1.8MM X 635MM LOT NUMBER: 65459439, ITEM NUMBER: 00-2232-004-18 ITEM NAME: CABLE-READY CABLE ASSY CERCLAGE COCR 1.8MM X 635MM LOT NUMBER: 65632345, ITEM NUMBER:00-2232-004-18 ITEM NAME: CABLE-READY CABLE ASSY CERCLAGE COCR 1.8MM X 635MM LOT NUMBER: 65656496. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2023 -00342, 0001825034 -2023 -00341. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, AS SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED .

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: H6: PROPOSED COMPONENT CODE: MECHANICAL (G04)- STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: RIGHT TOTAL HIP ARTHROPLASTY WITH IMPLANT DISSOCIATION AT THE JUNCTION OF THE FEMORAL HEAD AND NECK 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A DISLOCATED HIP AND DISASSOCIATED FEMORAL HEAD FROM STEM. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557716 BI-METRIC/X POR NC LAT 13X145 PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 386650

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention| H PLEASE SEE H10.