BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 58 MM O.D. SHELL

    MDR report key: 18753466 · Received February 21, 2024

    Report

    Report Number
    0001822565-2024-00620
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    January 26, 2024
    Report Date
    April 1, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K002960
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 00877503602, LOT# 3132882 ,BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14. CAT# 00784803300, LOT# 65603456, MODULAR NECK C 12/14 NECK TAPER USE WITH +0 HEADS ONLY. CAT# 00620205822, LOT# 65618055, SHELL POROUS WITH CLUSTER HOLES 58 MM. CAT# 00625006520, LOT# J7431772, BONE SCR 6.5X20 SELF-TAP. CAT# 00625006530, LOT# J7470747, BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH. CAT# 00771301200, LOT# 65603350, MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 12.5. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. 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. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED} 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. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL RIGHT THA WAS PERFORMED. A REVISION WAS PERFORMED DUE TO RECURRENT DISLOCATIONS. DURING THE REVISION IT WAS NOTED THERE WAS A COMPLAINT TEAR OF THE CAPSULAR REPAIR AND A LARGE AMOUNT OF SCAR TISSUE. 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 A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 8 MONTHS LATER DUE TO RECURRENT DISLOCATIONS. DURING THE REVISION, IT WAS NOTED THAT THE PATIENT¿S INITIAL CAPSULAR REPAIR WAS COMPLETELY TORN ON THE POSTERIOR CAPSULE WHICH HAD SCARRED DOWN POSTERIORLY CAUSING DISLOCATIONS. THE SCAR TISSUE WAS REMOVED WHICH INCREASED STABLE RANGE OF MOTION. THE HEAD, NECK, AND LINER WERE REPLACED WITH A CONSTRAINED SYSTEM WHICH FURTHER ENHANCED STABLE RANGE OF MOTION. THE INITIAL CUP AND STEM WERE LEFT INTACT, AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415949 LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 58 MM O.D. SHELL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64970915

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R