BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 13666462 · Received March 4, 2022

    Report

    Report Number
    1818910-2022-04080
    Event Type
    Injury
    Date Received
    March 4, 2022
    Date of Event
    May 2, 2021
    Report Date
    March 4, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE DEVICE TO EXAMINE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A DEVICE HISTORY RECORD (DHR) REVIEW OR MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    LITERATURE ARTICLE ENTITLED ¿RISK FACTORS FOR A RADIOLUCENT LINE AROUND THE ACETABULAR COMPONENT WITH AN INTERFACE BIOACTIVE BONE CEMENT TECHNIQUE AFTER PRIMARY CEMENTED TOTAL HIP ARTHROPLASTY¿. MIYAMOTO S, IIDA S, SUZUKI C, NAKATANI T, KAWARAI Y, NAKAMURA J, ORITA S, OHTORI S.. BONE JT OPEN. 2021 MAY;2(5):278-292. DOI: 10.1302/2633-1462.25.BJO-2021-0010.R1. PMID: 33940938; PMCID: PMC8168551. THE ARTICLE'S PURPOSE WAS TO IDENTIFY RISK FACTORS PREDICTIVE OF A RADIOLUCENT LINE (RLL) AROUND THE ACETABULAR COMPONENT. PATIENT SPECIFIC DATA: FEMALE, (B)(6), PRIMARY DIAGNOSIS: SECONDARY OA (DYSPLASIAL). FEMALE, (B)(6), PRIMARY DIAGNOSIS: SECONDARY OA (DYSPLASIAL). FEMALE, (B)(6), PRIMARY DIAGNOSIS: RAPIDLY DESTRUCTIVE COXOPATHY. FEMALE, (B)(6), PRIMARY DIAGNOSIS: SECONDARY OA (DYSPLASIAL). MALE, (B)(6), PRIMARY DIAGNOSIS: PRIMARY OA. FEMALE, (B)(6), PRIMARY DIAGNOSIS: SECONDARY OA (DYSPLASIAL). FEMALE, (B)(6), PRIMARY DIAGNOSIS: RHEUMATOID ARTHRITIS. FEMALE, (B)(6), PRIMARY DIAGNOSIS: SECONDARY OA (CONGENITAL DISLOCATION). MALE, (B)(6), PRIMARY DIAGNOSIS: SECONDARY OA (DYSPLASIAL). FEMALE, (B)(6), PRIMARY DIAGNOSIS: SECONDARY OA (DYSPLASIAL). PATIENT NON-SPECIFIC DATA: THE MEAN PATIENT AGE WAS 66.6 YEARS. THE MAJORITY OF THE PATIENTS WERE FEMALE, AND THE MOST COMMON PREOPERATIVE DIAGNOSIS WAS SECONDARY OSTEOARTHRITIS. IT IS NOTED THAT IMPLANTS IN THE STUDY WERE A COMBINATION OF DEPUY AND COMPETITOR PRODUCTS. THE STUDY ONLY ADDRESSES THE ACETABULAR CUP COMPONENTS. THE MANUFACTURER OF THE FEMORAL STEM, FEMORAL HEAD AND CEMENT IS UNKNOWN. DEPUY PRODUCTS: CHARNLEY ELITE PLUS OGEE ALL POLY CUP AND CHARNLEY OGEE ALL POLY CUP PATIENT SPECIFIC ADVERSE EVENTS (CORRESPONDING TO THE ABOVE PATIENT SPECIFIC DATA): ACETABULAR BONE FRACTURE, JOINT DISLOCATION WITH CUP LOOSENING AND MIGRATION¿ REVISION. INFECTION XRAY RADIOLUCENT LINES ¿ REVISION 2 STAGE. CUP LOOSENING AND MIGRATION ¿ REVISION. INFECTION XRAY RADIOLUCENT LINES ¿ REVISION 2 STAGE. INFECTION XRAY RADIOLUCENT LINES ¿ REVISION 2 STAGE. SUPERIOR CUP LOOSENING AND MIGRATION ¿ REVISION. XRAY RADIOLUCENT LINES ¿ REVISION. INFECTION ¿ REVISION 2 STAGE. INFECTION ¿ REVISION 2 STAGE. INFECTION ¿ REVISION 2 STAGE. NON-PATIENT SPECIFIC ADVERSE EVENTS. PATIENT SPECIFICS AND OCCURRENCE RATES PER DEPUY PRODUCT NOT PROVIDED. TREATMENT FOR AES ALSO NOT PROVIDED WITH THE EXCEPTION OF THE DISLOCATION: PAIN. DECREASED RANGE OF MOTION AND WALKING DIFFICULTY. (6) DISLOCATION ¿ CLOSED REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963820 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention