BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER STANDARD 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS

    MDR report key: 15633027 · Received October 19, 2022

    Report

    Report Number
    0002648920-2022-00220
    Event Type
    Injury
    Date Received
    October 19, 2022
    Date of Event
    September 21, 2022
    Report Date
    November 4, 2022
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    UDI-DI
    00889024123755
    PMA / PMN Number
    K990135
    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). CONCOMITANT MEDICAL PRODUCTS: REF (B)(4) LOT 65229971 M/L TAPER FEMORAL STEM SIZE 12.5. REF (B)(4) LOT 64932913 TM SHELL WITH CLUSTER HOLES, REF (B)(4) LOT 65203293 SELF TAPING SCREW 6.5MM X 25MM, REF (B)(4) LOT J7214208 SELF TAPING SCREW 6.5MM X 30MM, REF (B)(4) LOT 65251232 KINECTIV 12/14 NECK TAPER- MODULAR NECK G, REF (B)(4) LOT 3092461 BIOLOX DELTA CERAMIC FEMORAL HEAD 32/0, TAPER 12/14, REF (B)(4) LOT 0002376673 JUGGERKNOT SOFT ANCHOR 2 # 2 MAXBRAID, REF (B)(4) LOT 0002398343 JUGGERKNOT SOFT ANCHOR 2 # 2 MAXBRAID. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE WAS DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: REPORTED EVENT WAS CONFIRMED VIA MEDICAL RECORDS AND RADIOGRAPHS REVIEWED BY A HEALTH CARE PROFESSIONAL. 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. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO THE PATIENT NOT FOLLOWING INSTRUCTIONS AND PERFORMING MOVEMENTS THAT RESULTED IN DISLOCATIONS. 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 A LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY 3 MONTHS LATER, PATIENT FELT A POP A COUPLE OF TIMES AND MANIPULATIONS WERE PERFORMED TO CORRECT THE DISLOCATIONS. APPROXIMATELY ONE MONTH LATER, PATIENT UNDERWENT A REVISION DUE TO THE RECURRENT DISLOCATIONS. DURING THE REVISION, THE POSTERIOR CAPSULAR STRUCTURES WERE NOTED TO BE TORN OFF THE POSTERIOR GREATER TROCHANTER AND SCARRED DOWN POSTERIORLY OVER THE SCIATIC NERVE. TISSUES WERE DEBRIDED AROUND THE PROXIMAL FEMUR AND DISSECTED AROUND THE PERIMETER OF THE ACETABULAR BASE. LARGE AMOUNTS OF SCAR TISSUE WERE FOUND ANTERIORLY. THE SURGERY WAS COMPLETED WITHOUT COMPLICATION AND THE HEAD, TAPER, AND LINER WERE EXCHANGED WHILE THE ACETABULUM AND STEM WERE FOUND WELL FIXED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2932240 LINER STANDARD 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 64893916 00889024123755

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE