BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN POLY LINER

    MDR report key: 11108540 · Received January 4, 2021

    Report

    Report Number
    0002249697-2021-00015
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    November 11, 2020
    Report Date
    May 20, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING WEAR INVOLVING A LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION OF THE PROVIDED IMAGES HAS BEEN PERFORMED AND STATED THAT - WHITE ARROWS POINT OUT DARKENED AREAS CONSISTENT WITH DISCOLORATION DUE TO METALLOSIS. RED ARROW POINT TO DAMAGE CONSISTENT WITH EXPLANTATION TOOL USE. MAR HAS BEEN PROVIDED FOR RETURNED PRODUCT AND STATED THAT - EVIDENCE WAS FOUND OF METALLOSIS, (AN INTERACTION BETWEEN IMPLANTED ALLOYS AND BODY TISSUE AND/OR FLUID), SEEN AS DISCOLORATION OF THE RETURNED DEVICES; PARTICULARLY THE UHMWPE X3 LINER. THE ANALYSIS CONDUCTED DID NOT FIND MATERIAL NON-CONFORMANCES, NOR INDICATIONS OF MANUFACTURING DEFECTS. DIMENSIONAL AND FUNCTIONAL INSPECTION NOT PERFORMED AS DEVICE WAS RETURNED IN DAMAGE CONDITION. -CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS STATED THAT - I CANNOT CONFIRM THAT THIS EVENT TOOK PLACE SINCE I WAS NOT ABLE TO SEE ANY DOCUMENTATION OTHER THAN A LETTER. NO OPERATION REPORT AND NO XRAYS WERE PROVIDED. REGARDING THE POSSIBLE ROOT CAUSE OF THIS EVENT, I CANNOT DETERMINE IT WITH CERTAINTY. CAUSES OF POLY WEAR ARE MULTIFACTORIAL INCLUDING SURGICAL TECHNIQUE FACTORS, PATIENT FACTORS SUCH AS ACTIVITY LEVEL AND BMI, AND IMPLANT FACTORS. -PRODUCT HISTORY REVIEW: NOT PERFORMED AS DEVICE WAS NOT PROPERLY IDENTIFIED. -COMPLAINT HISTORY REVIEW: NOT PERFORMED AS DEVICE WAS NOT PROPERLY IDENTIFIED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO WEAR. CLINICAL REVIEW WAS PROVIDED AND STATED THAT A REVIEW OF THE PROVIDED MEDICAL RECORDS STATED THAT - I CANNOT CONFIRM THAT THIS EVENT TOOK PLACE SINCE I WAS NOT ABLE TO SEE ANY DOCUMENTATION OTHER THAN A LETTER. NO OPERATION REPORT AND NO XRAYS WERE PROVIDED. REGARDING THE POSSIBLE ROOT CAUSE OF THIS EVENT, I CANNOT DETERMINE IT WITH CERTAINTY. CAUSES OF POLY WEAR ARE MULTIFACTORIAL INCLUDING SURGICAL TECHNIQUE FACTORS, PATIENT FACTORS SUCH AS ACTIVITY LEVEL AND BMI, AND IMPLANT FACTORS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PATHOLOGY REPORTS, PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED - THE PATIENT WHO UNDERWENT RIGHT HIP REPLACEMENT SURGERY IN (B)(6) 2010. CONSULTATION IN EARLY 2020 FOR PAINFUL SYMPTOMS. THE POLYETHYLENE COMPONENT OF HER PROSTHESIS WAS FOUND TO BE VERY WORN, WITH A VERY PROBABLE RISK OF METALLOSIS, WHICH COULD BE THE CAUSE OF HER PAIN.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED - THE PATIENT WHO UNDERWENT RIGHT HIP REPLACEMENT SURGERY IN (B)(6) 2010. CONSULTATION IN EARLY 2020 FOR PAINFUL SYMPTOMS. THE POLYETHYLENE COMPONENT OF HER PROSTHESIS WAS FOUND TO BE VERY WORN, WITH A VERY PROBABLE RISK OF METALLOSIS, WHICH COULD BE THE CAUSE OF HER PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4724 UNKNOWN POLY LINER PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization| R