BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 10° ANGLE FOR PIP ARTHRO

    MDR report key: 5011190 · Received August 18, 2015

    Report

    Report Number
    0008031020-2015-00353
    Event Type
    Injury
    Date Received
    August 18, 2015
    Date of Event
    July 21, 2015
    Report Date
    July 21, 2015
    Manufacturer
    STRYKER GMBH
    Product Code
    LZJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED INCIDENT THAT INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 10° ANGLE FOR PIP ARTHRO WAS ALLEGED OF ISSUE S-12 (IMPLANT BREAKAGE AFTER SURGERY) COULD BE CONFIRMED SINCE WE RECEIVED X RAYS SHOWING THE BROKEN DEVICE. BASED ON THE CURRENTLY AVAILABLE INFORMATION, THE ROOT CAUSE CAN BE ATTRIBUTED TO A PATIENT RELATED ISSUE. THE NORMAL RANGE TIME FOR OSTEOSYNTHESIS AND BONE CONSOLIDATION IS 4 TO 6 WEEKS. IT WAS REPORTED THAT THE BREAKAGE WAS NOTICED 4 WEEKS AFTER IMPLANTATION BUT THE PATIENT IS 75 YEARS OLD; THEREFORE THE BONE HEALING TIME AND OSTEOSYNTHESIS PERIOD IS CLOSER TO 6 WEEKS THAN 4 WEEKS IN THIS CASE. MOREOVER, THE PATIENT HAS OVERWEIGHT (BMI=28.2). IN THIS CASE, THE PATIENT SHOULD HAVE OBSERVED A NON-WEIGHT BEARING PERIOD OF 6 WEEKS AND SHOULD HAVE WAIT FOR BONE CONSOLIDATION CONFIRMATION BY THE SURGEON. THEREFORE THIS CASE IS CLASSIFIED AS PATIENT RELATED. PLEASE NOTE THAT THE OPERATIVE TECHNIQUE READS: ¿SMARTTOE IMPLANTS ARE NOT INTENDED FOR IMMEDIATE POSTOPERATIVE WEIGHT BEARING. BE SURE THAT THE POSTOPERATIVE LOADING OF THE INTERNAL FIXATION IS REDUCED TO A MINIMUM (E.G. WITH APPLICATION OF A FOREFOOT OFF-LOADING SHOE) UNTIL BONE CONSOLIDATION IS CONFIRMED BY FOLLOW UP X-RAY EXAMINATION (NORMALLY AFTER 4 - 6 WEEKS). [PAGES 5 & 14]¿ [ORIGINAL STATEMENT(S)] PLEASE NOTE THAT THE IFU READS: ¿- THE PRODUCT DOES NOT ALLOW THE IMMEDIATE RESUMPTION OF ACTIVITY BY THE PATIENT AND IS NOT DESIGNED TO SUPPORT AN IMMEDIATE LOAD. IMMOBILIZATION IS NECESSARY DURING THE OSTEOSYNTHESIS. [¿] - IT IS NECESSARY TO INFORM THE PATIENT OF THE PRECAUTIONS TO BE TAKEN TO ENSURE THE SUCCESS OF THE IMPLANTATION. [...] FACTORS CAPABLE OF COMPROMISING IMPLANTATION SUCCESS. - BONE PATHOLOGY, OSTEOPOROSIS, BONE TUMORS, SYSTEMIC OR METABOLIC PROBLEMS AND INFECTIOUS DISEASES. - SENILITY, MENTAL ILLNESS, ABUSE OF ILLEGAL DRUGS, PRESCRIPTION DRUGS OR ALCOHOL. - EXCESS WEIGHT, INTENSE PROFESSIONAL OR SPORTING PHYSICAL ACTIVITY THAT EXPOSES THE IMPLANT TO EXCESSIVE OR REPEATED LOADS. - RISK OF CONFLICT WITH OTHER IMPLANTS. - RISK OF ARTICULAR CONFLICT.¿ [ORIGINAL STATEMENT(S)] A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. UNK SMART TOE IMPLANT. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY THE SURGEON THAT AFTER 4 WEEKS OF THE IMPLANTATION OF A SMART TOE IMPLANT, THE X-RAY IMAGES REVEAL THAT THE IMPLANTS ARE BROKEN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY THE SURGEON THAT AFTER 4 WEEKS OF THE IMPLANTATION OF A SMART TOE IMPLANT, THE X-RAY IMAGES REVEAL THAT THE IMPLANTS ARE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546471 INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 10° ANGLE FOR PIP ARTHRO IMPLANT LZJ STRYKER GMBH J06886

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention