BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 13996044 · Received April 4, 2022

    Report

    Report Number
    1818910-2022-06081
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    January 1, 2022
    Report Date
    April 4, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THERE ARE NO ATTACHED IMAGES WITHIN THE ARTICLE. BASED ON THE PROVIDED INFORMATION, IT IS NOT POSSIBLE TO IDENTIFY ANY DEPUY'S PRODUCT MALFUNCTION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED FOR THIS DEVICE. REMOVED THE CONCOMITANT PRODUCTS REPORTED IN THE INITIAL MEDWATCH SINCE LITERATURE COMPLAINTS DO NOT HAVE CONCOMITANT PRODUCTS.

    Description of Event or Problem · 0

    LITERATURE ARTICLE ENTITLED ¿PERIPROSTHETIC FEMUR FRACTURE RISK: INFLUENCED BY STEM CHOICE, NOT SURGICAL APPROACH.¿ WRITTEN BY SERSHON RA, MCDONALD JF 3RD, HO H, HAMILTON WG. J ARTHROPLASTY. PUBLISHED 23 FEB 2021. PMID: 33736894. THE ARTICLE'S PURPOSE WAS TO ¿DETERMINE THE 90-DAY RELATIVE RISK OF PFF WITH REGARD TO APPROACH AND STEM DESIGN.¿ PATIENT DATA: A TOTAL OF 6309 CASES PERFORMED. THERE WERE 3678 WOMEN IN THE STUDY. AGE 64 ± 10.9 YEARS, HEIGHT INCHES 67 ± 4.0, WEIGHT LBS 185 ± 43.0. IT IS NOTED THAT IMPLANTS IN THE STUDY WERE A COMBINATION OF DEPUY AND COMPETITOR PRODUCTS. DEPUY PRODUCTS: CORAIL STEM, TRILOCK STEM, ACTIS STEM, SUMMIT STEM NON-PATIENT SPECIFIC ADVERSE EVENTS: INTRA-OPERATIVE FEMORAL BONE FRACTURE ¿ CONSERVATIVE TREATMENT INTRA-OPERATIVE FEMORAL BONE FRACTURE ¿ SURGICAL TREATMENT WITH CABLE PLACEMENT OR REQUIRING INTRAOPERATIVE STEM CHANGE. POST-OPERATIVE PERIPROSTHETIC FEMORAL BONE FRACTURE ¿ CONSERVATIVE TREATMENT POST-OPERATIVE PERIPROSTHETIC FEMORAL BONE FRACTURE ¿ SURGICAL TREATMENT OF EITHER POSTOPERATIVE REVISION ARTHROPLASTY, OR POSTOPERATIVE OPEN REDUCTION INTERNAL FIXATION. LITERATURE IS A VALUABLE SOURCE OF INFORMATION. HOWEVER, IT HAS LIMITATIONS, INCLUDING NONSPECIFIC AND INDETERMINATE INFORMATION ABOUT EACH ADVERSE EVENT. THE AUTHORS DO NOT PROVIDE INFORMATION TO IDENTIFY THE DEVICES USED DURING PRIMARY PROCEDURE FOR EACH PATIENT. THE ADVERSE EVENTS CAPTURED IN THIS COMPLAINT ARE THE EVENTS THAT COULD BE ASSOCIATED WITH THE NOTED DEPUY SYNTHES DEVICES. THE EVENTS THAT ARE ASSOCIATED WITH COMPETITOR DEVICES ARE EXCLUDED FROM THIS COMPLAINT. THE ACTUAL NUMBER AND SPECIFIC PRODUCT LINE OF DEPUY SYNTHES DEVICES ASSOCIATED WITH THE ABOVE ADVERSE EVENTS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78427 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention UNK HIP FEMORAL STEM CORAIL| UNK HIP FEMORAL STEM CORAIL| UNKNOWN HIP FEMORAL STEM| UNKNOWN HIP FEMORAL STEM