BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM MULTI HOLE ACETABULAR SHELL

    MDR report key: 4112602 · Received September 10, 2014

    Report

    Report Number
    1822565-2014-01100
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    September 5, 2020
    Report Date
    April 19, 2023
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PK093561
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE LINER AND SHELL ARE CONFIRMED COMPATIBLE. NEITHER OPERATIVE NOTES NOR X-RAYS HAVE BEEN PROVIDED FOR REVIEW. THE COMPONENT FIT AND ORIENTATION PER THE SURGICAL TECHNIQUE IS UNK. IN GENERAL, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. REHABILITATION PROTOCOL AND ADHERENCE THERE TO IS UNK. WITH THE INFO PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.: IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR'S WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT(S): 0001822565 - 2018 - 05391 NO DEVICE OR ADDITIONAL INVESTIGATIONAL INPUTS WERE RETURNED FOR EVALUATION. REVIEW OF THE KNOWN PRODUCT/LOT CODE COMBINATIONS DEVICE HISTORY RECORDS IDENTIFIED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DEVICE HISTORY REVIEW WAS UNABLE TO BE COMPLETED FOR THE UNKNOWN PART/LOT FEMORAL STEM. ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE LIMITED INFORMATION MADE AVAILABLE. 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 · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAS PAIN, HAS DIFFICULTY AMBULATING, FEELS IMPLANT IS MIGRATING, AND HAS NUMBNESS AFTER A FALL. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559188 TM MULTI HOLE ACETABULAR SHELL KWZ KWZ ZIMMER, INC. 60560945

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other| H| R LOT #60525995, CATALOG #00631005028.| MANUFACTURED BY ZIMMER B.V., PONCE, PR.| TRILOGY LONGEVITY POLY LINER:| TRILOGY LONGEVITY POLY LINER:| MANUFACTURED BY ZIMMER B.V., PONCE, PR.| LOT #60525995, CATALOG #00631005028