BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINN CAN BONE SCREW 6.5MMX25MM

    MDR report key: 12727763 · Received November 1, 2021

    Report

    Report Number
    1818910-2021-24096
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    October 13, 2021
    Report Date
    October 19, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295009900
    PMA / PMN Number
    K983014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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 : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MATERIAL, MANUFACTURING, INSPECTION OR STERILE PROCESSING THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR MEDIAL ACETABULAR WALL FX WITH MILD MIGRATION AND LOOSENING OF THE CUP. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS RELATED TO DEVICE AND NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2020, DATE OF EVENT: (B)(6) 2021, (RIGHT HIP). TREATMENT: NONE. DEPUY COMPONENTS USED: CATALOG ID: 136534000, LOT ID: 9492039, COMPONENT TYPE: HEAD, DESCRIPTION: S-ROM M HEAD 36MM+9. CATALOG ID: 122136452, LOT ID: J9459W, COMPONENT TYPE: LINER, DESCRIPTION: PINNACLE ALTRX 52MM X 36MM +4 NEUTRAL . CATALOG ID: 563517, LOT ID: 9437860, COMPONENT TYPE: STEM, DESCRIPTION: SROM STEM STD 36MM +6L NECK 16.0MM X 11MM X 150MM. CATALOG ID: 550514, LOT ID: 8771191, COMPONENT TYPE: SLEEVE, DESCRIPTION: SROM SLEEVE PROXIMAL TITANIUM 16D LG. CATALOG ID: 121715500, LOT ID: D19083058, COMPONENT TYPE: SCREW, DESCRIPTION: CANCELLOUS BONE SCREW. CATALOG ID: 121720500, LOT ID: D19072475, COMPONENT TYPE: SCREW, DESCRIPTION: PINNACLE CANCELLOUS BONE SCREW 6.5 MM X 20 MM. CATALOG ID: 121725500, LOT ID: D20033010, COMPONENT TYPE: SCREW, DESCRIPTION: CANCELLOUS BONE SCREW 25MM. CATALOG ID: 121715500, LOT ID: D20051768, COMPONENT TYPE: SCREW, DESCRIPTION: CANCELLOUS BONE SCREW. CATALOG ID: 121730052, LOT ID: J9265U, COMPONENT TYPE: SHELL, DESCRIPTION: PINNACLE MULTIHOLE SERIES GRIPTION ACETABULAR SHELL SZ 52MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624768 PINN CAN BONE SCREW 6.5MMX25MM BONE SCREWS AND PINS : SCREWS LPH DEPUY ORTHOPAEDICS INC US 1217-25-500 D20033010 10603295009900

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male ALTRX +4 NEUT 36IDX52OD| PINN CAN BONE SCREW 6.5MMX15MM| PINN CAN BONE SCREW 6.5MMX15MM| PINN CAN BONE SCREW 6.5MMX20MM| PINN CAN BONE SCREW 6.5MMX25MM| PINN MULTIHOLE W/GRIPTION 52MM| S-ROM M HEAD 36MM +9| S-ROM*SLEEVE PRX ZTT, 16D-LRG| SROM STM ST,36+6L NK,11X16X150