BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELL POROUS WITH CLUSTER HOLES 54 MM

    MDR report key: 14270949 · Received May 3, 2022

    Report

    Report Number
    0001822565-2022-01261
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    March 29, 2022
    Report Date
    January 25, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024118911
    PMA / PMN Number
    K093561
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00625006525, BONE SCREW, J7097559. 00625006520, BONE SCREW, J7133077. UNKNOWN STRYKER HEAD, UNKNOWN PART AND LOT. UNKNOWN STRYKER STEM, UNKNOWN PART AND LOT. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2022 - 01262.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. VISUAL INSPECTION OF THE PICTURES PROVIDED IDENTIFIED THE LINER TO BE FRACTURED, THE FRACTURED LINER IDENTIFIED THE HEAD TO GET IN CONTACT WITH THE SHELL AND CAUSE WEAR. THE SHELL METAL SUBSTANCE WAS IDENTIFIED ON THE HEAD. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE COULD NOT 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-01262-5. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED BIO DEBRIS EMBEDDED IN THE TM SURFACE OF THE SHELL. LOCK RING WAS NOT IN THE SHELL AND PARTIALLY WORN AWAY. SHELL SHOWS WEAR FROM THE HEAD THAT GOES THROUGH THE METAL SUBSTRATE TO THE TM PAD. NICKS, GOUGES, SCRATCHES, AND DEFORMATION ARE NOTED AROUND THE SHELL. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THE SHELL AND THE REPORTED PART AND LOT COMBINATION. ROOT CAUSE UNCHANGED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 16 MONTH POST IMPLANTATION DUE TO THE LINER COMPONENT FRACTURING. DURING THE PROCEDURE IT WAS FOUND THAT THE SHELL WAS DEFORMED AND THERE WAS METALLOSIS AND JOINT DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT DETAILS TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001202 SHELL POROUS WITH CLUSTER HOLES 54 MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 63494045 00889024118911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R SEE H10 NARRATIVE.| SEE H10.