BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIP SZ. 20 PROXIMAL

    MDR report key: 15048307 · Received July 18, 2022

    Report

    Report Number
    3002788818-2022-00049
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    June 23, 2022
    Report Date
    September 13, 2022
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    OMX
    UDI-DI
    10381780000471
    PMA / PMN Number
    H010005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: AS THE PRODUCT HAS NOT BEEN RECEIVED AT THE AUS SITE FOR EVALUATION AND PHOTOGRAPHS WERE NOT PROVIDED, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE FOLLOWING INVESTIGATIVE ACTIONS WERE PERFORMED. REFER TO THE RESPECTIVE TASKS FOR FURTHER DETAIL. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY REVIEW IDENTIFIED SIMILAR REPORTED EVENTS FOR THIS DEVICE BUT NOT FOR THE SAME PRODUCT LOT. FUTURE COMPLAINTS FOR THIS FAILURE MODE WILL CONTINUE TO BE MONITORED AND INVESTIGATED AS REQUIRED. RISK MANAGEMENT REVIEW (DEVICE): IDENTIFIED NO ISSUES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE FAILURE MODE WAS PREVIOUSLY IDENTIFIED BY THE RISK MANAGEMENT FILE AND THE ANTICIPATED RISK LEVEL IS ACCEPTABLE. DHR/BATCH RECORD REVIEW: IDENTIFIED NO ISSUES OR MANUFACTURING ABNORMALITIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS REVIEW DETERMINED THAT THE DEVICE MET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. CAPA/NC/PRA/HHE/FIELD ACTION REVIEW: IDENTIFIED NO PREVIOUS EVENTS OR ISSUES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ASSESSMENT OF HISTORICAL ESCALATED CASES CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS DEVICE AND FAILURE MODE. DEVICE LABELING/IFU REVIEW: IDENTIFIED NO ISSUES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS REVIEW DETERMINED THAT THE DEVICE MET LABELING REQUIREMENTS UPON RELEASE FOR DISTRIBUTION. PRODUCT PRINTS/SPECIFICATIONS/PROCEDURE REVIEW: IDENTIFIED NO ISSUES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS REVIEW DETERMINED THAT THE DEVICE MET PRODUCT SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. CLINICAL/MEDICAL EVALUATION: COULD NOT DETERMINE PROBABLE CAUSE OR CONTRIBUTING FACTORS AS SMITH AND NEPHEW HAS NOT RECEIVED THE REQUESTED PATIENT SPECIFIC DOCUMENTATION, THE EXPLANTED DEVICE, AND/OR ADEQUATE MATERIALS TO FULLY EVALUATE THE ROOT CAUSE OF THE COMPLAINT. AS THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT ALLEGES THAT MEDICAL INTERVENTION BEYOND THE STANDARD OF CARE WAS REQUIRED TO ADDRESS THE REPORTED EVENT. AS THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION, IT COULD NOT BE DETERMINED WHETHER THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES AGAINST THE DEVICE¿S MANUFACTURING SPECIFICATIONS WERE IDENTIFIED. THE PIP PROXIMAL IMPLANT IS AN IMPLANTABLE DEVICE MADE OF PYROCARBON, A MATERIAL WHICH IS KNOWN TO EXHIBIT BRITTLE OVERLOAD FRACTURE WHEN SUBJECTED TO EXCESSIVE OR BENDING FORCES. INTRA-OPERATIVE FRACTURE IS A KNOWN FAILURE MODE FOR THE PIP IMPLANT AS DOCUMENTED IN THE RISK-BENEFIT ANALYSIS FOR THE PIP PRODUCT LINE. POTENTIAL ROOT CAUSES INCLUDE INADEQUATE OR INCORRECT SURGICAL TECHNIQUE, SUCH AS INCORRECT BONE PREPARATION, AND INCORRECT HANDLING OF THE IMPLANT. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED AS NO NON-CONFORMANCES OR PRODUCT DEFICIENCIES WERE IDENTIFIED AND THE RISK LEVEL IS ACCEPTABLE. IF ADDITIONAL INFORMATION IS LATER RECEIVED, THE COMPLAINT MAY BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT, THOUGH FUTURE COMPLAINTS WILL BE MONITORED AND INVESTIGATED AS REQUIRED. THIS INVESTIGATION CAN BE CLOSED. INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A PIP TOTAL JOINT SURGERY, THE PIP SZ. 20 PROXIMAL SHEARED OFF WHEN IMPACTED GENTLY INTO THE PATIENT¿S MIDDLE PHALANGEAL BONE OF PATIENT LEFT RING FINGER. THE IMPLANT STEM WAS EMBEDDED IN THE PATIENT MEDULLARY CANAL AND IT WAS REMOVED USING A K WIRE DRILLED INTO THE MIDDLE PHALANX, PROXIMAL TO THE IMPLANT, BEFORE IMPLANTING A REPLACEMENT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313977 PIP SZ. 20 PROXIMAL HIGH DEMAND, REVISION, SEMI-CONSTRAINED, PYROLYTIC CARBON, UNCEMENTED FINGER PRO OMX ASCENSION ORTHOPEDICS, INC. PIP-200-20P-WW 195590T 10381780000471

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention