BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLOC 12/14 POR 10X140

    MDR report key: 11776459 · Received May 5, 2021

    Report

    Report Number
    3002806535-2021-00155
    Event Type
    Injury
    Date Received
    May 5, 2021
    Date of Event
    April 8, 2021
    Report Date
    June 7, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. ONE ANTEROPOSTERIOR FULL-PELVIS X-RAY WAS PROVIDED FOR ANALYSIS WITH (B)(4). THE X-RAY SHOWS THE TAPERLOC STEM FRACTURED IN THE NECK REGION. THE INCLINATION ANGLE OF THE AVANTAGE SHELL WAS MEASURED TO BE 47.4 DEGREES (IMAGEJ V1.52N, NIH, USA) IN THE PROVIDED RADIOGRAPH, WHICH IS HIGHER THAN THE RECOMMENDED SURGICAL INCLINATION ANGLE IN THE AVANTAGE SURGICAL TECHNIQUE OF 40 TO 45 DEGREES OF INCLINATION. THE COMPLAINT DESCRIPTION MENTIONS THAT THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2004. ON (B)(6) 2016, A NEW HEAD, SHELL AND LINER WERE IMPLANTED. LINKED COMPLAINTS C(B)(4) AND (B)(4) COVER THIS FIRST REVISION SURGERY, WHICH WAS PERFORMED DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION COULD BE OBTAINED RELATED TO THIS REVISION. THE FEMORAL STEM IS REPORTED ON THE ZIMMER BIOMET PRODUCT EXPERIENCE REPORT (ZPER) TO HAVE BROKEN ON (B)(6) 2021, WITH THE SECOND REVISION SURGERY BEING PERFORMED ON (B)(6) 2021. IT IS STATED THAT HERE IS A FRACTURE OF THE FEMORAL STEM AT THE NECK LEVEL WITH MODERATE DISPLACEMENT. THERE IS NO OSSEOUS FRACTURE OR DISLOCATION. BONE QUALITY IS OSTEOPENIC AND THAT THE ACETABULAR CUP ABDUCTION MEASURES APPROXIMATELY 51 DEGREES. THE ZPER MENTIONS THAT THE SURGICAL TECHNIQUE FOR THE PRODUCT WAS UTILISED AND THAT THE AVAILABLE INFORMATION SUGGESTS THAT THE DEVICE HAS MALFUNCTIONED OR FAILED TO PERFORM AS INTENDED. THE ZPER ALSO STATES THAT THE PATIENT IS MALE, WAS 76 YEARS OLD AT THE TIME OF THE SECOND REVISION SURGERY, AND HAS A SMALL BUILD, ALTHOUGH NO INFORMATION ABOUT HEIGHT AND WEIGHT IS PROVIDED. THE MANUFACTURING HISTORY RECORDS (MHRS) FOR THE TAPERLOC 12/14 POROUS-COATED FEMORAL STEM HAS BEEN CHECKED AND VERIFIES THAT THE COMPONENT WAS MANUFACTURED AND STERILISED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. THE INSTRUCTIONS FOR USE PROVIDED WITH THE FEMORAL STEM MENTION THE FOLLOWING: WARNINGS AND PRECAUTIONS: IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT MAY RESULT IN UNUSUAL STRESS CONDITIONS AND A SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE IMPLANT. PATIENT WARNINGS: THE PATIENT MUST BE WARNED THAT THE DEVICE DOES NOT REPLACE NORMAL HEALTHY BONE, AND THAT THE IMPLANT CAN BREAK OR BE DAMAGED AS A RESULT OF EXCESSIVE LOAD BEARING OR TRAUMA. IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF IMPLANT FRACTURE WITHOUT EXAMINATION OF THE EXPLANTED COMPONENTS, AND WITHOUT PROVISION OF POST-PRIMARY X-RAYS, SURGICAL NOTES AND PATIENT INFORMATION SUCH AS HEIGHT, WEIGHT AND ACTIVITY LEVEL. HOWEVER, IT IS POSSIBLE THAT SUBOPTIMAL POSITIONING OF THE ACETABULAR COMPONENTS IMPLANTED IN 2016 MAY HAVE BEEN A CONTRIBUTING FACTOR. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO COMPLAINT REPORTED WITH THE ITEM 650-0320. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION, FURTHERMORE, THE SUPPLIED PHOTOGRAPH DOES NOT YIELD ANY INFORMATION THAT COULD IDENTIFY THE CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    PRIMARY SURGERY TOOK PLACE ON (B)(6) 2004. IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION ON (B)(6) 2016 DUE TO UNKNOWN REASONS WHEN THE HEAD, CUP AND LINER WERE REMOVED AND REPLACED ((B)(4)). SUBSEQUENTLY, A SECOND REVISION PROCEDURE DUE TO BROKEN STEM NECK WAS PERFORMED ON (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT HAS BEEN DISCARDED. CONCOMITANT MEDICAL PRODUCTS(ASSOCIATED PRODUCTS): MEDICAL PRODUCT: REFOBACIN REVISION 40G, CATALOG #: 4011630001, LOT #: UNK; MEDICAL PRODUCT: COCR HD LN NECK D22.2/+2 12/14, CATALOG #: P0206L22, LOT #: UNK; MEDICAL PRODUCT: AVAN CMNTD SHELL SS 44MM, CATALOG #: P0463044, LOT #: UNK; MEDICAL PRODUCT: AVAN INSERT 44/22, CATALOG #: P0560044, LOT #: UNK. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PRIMARY SURGERY TOOK PLACE ON (B)(6) 2004. IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION ON (B)(6) 2004. SUBSEQUENTLY, A SECOND REVISION PROCEDURE DUE TO BROKEN STEM NECK WAS PERFORMED ON (B)(6) 2021 .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674361 TPRLOC 12/14 POR 10X140 HIP ARTHROPLASTY LPH BIOMET UK LTD. N/A 721626

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R