BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°

    MDR report key: 5634431 · Received May 5, 2016

    Report

    Report Number
    0009610622-2016-00240
    Event Type
    Injury
    Date Received
    May 5, 2016
    Date of Event
    April 11, 2016
    Report Date
    April 11, 2016
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CAT 3060-0-110S LAG SCREW, TI GAMMA3® Ø10.5X110MM LOT CODE K103248; CAT 1896-5-035S LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 MM LOT CODE K117625. EVALUATION REVEALED THE REPORTED TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° TO BE THE PRIMARY PRODUCT. THE FURTHER REPORTED LAG SCREW, TI GAMMA3® Ø10.5X110MM AND THE LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 MM DID NOT CONTRIBUTE TO THE REPORTED EVENT AND ARE CLASSIFIED AS CONCOMITANT PRODUCTS. THE REVIEW OF MANUFACTURING DOCUMENTS REVEALED NO DEVIATION IN THE MANUFACTURING PROCESS RESP. NO DEVIATION IN MATERIAL. POTENTIAL PAIN HAD BEEN CONSIDERED IN THE CORRESPONDING RMF. THE THRESHOLD WAS NOT EXCEEDED. A REVIEW OF THE CAPA DATABASE REVEALED NO CORRECTIVE ACTIONS RELATED TO THE REPORTED EVENT IN PLACE FOR THE SUBJECT PRODUCT. THE EVENT DID NOT INVOLVE A PRODUCT PROBLEM INDICATING A NON-CONFORMITY, ADVERSE TREND OR UNANTICIPATED HAZARD. NO FURTHER ACTION IS REQUIRED AT THIS TIME. A PHYSICAL EXAMINATION COULD NOT BE CARRIED OUT AS THE DEVICE WAS NOT RETURNED TO STRYKER (B)(4) (THE NAIL IS STILL IMPLANTED). ANY X-RAYS OR SURGICAL REPORTS WERE NOT PROVIDED EITHER THOUGH REQUESTED SEVERAL TIMES. IN THE CASE PRESENTED A MALE PATIENT ((B)(6) AT TIME OF THE EVENT) HAD BEEN TREATED WITH A TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ON (B)(6) 2010 DUE TO A FRACTURE OF THE RIGHT HIP. THE PATIENT STATED THAT HE IS SUFFERING FROM PAIN SINCE SURGICAL PROCEDURE. ANY FURTHER INFORMATION IS NOT AVAILABLE. GENERAL STATEMENT REGARDING RISK / BENEFIT ANALYSIS OF A MEDICAL EXPERT: THE GIVEN ESTIMATION IS NOT ONLY SPECIFIC FOR GAMMA3 BUT FOR ALL PROXIMAL FEMUR NAILS. THE BENEFIT FAR OVERWEIGHTS THE RISKS OF THE SURGICAL PROCEDURE. PAIN IS A TYPICAL COMPLICATION OF PROXIMAL FEMORAL NAILING. THIS HARM DOES NOT PRIMLY DEPEND ON THE IMPLANT. IT IS MOSTLY CAUSED BY THE KIND OF FRACTURE, PATIENT'S GENERAL CONDITION (OSTEOPOROSIS), AND PRIMLY THE RESPECTIVE SURGICAL TECHNIQUE. PAIN MAY BE TOLERABLE WITH ANALGETIC AND ANTIPHLOGISTIC MEDICATION (S3) OR WOULD CAUSE SIGNIFICANT PERMANENT HARM (S4) EVEN WITH MORPHINS. ACCORDING TO LITERATURE THE OCCURRENCE RATE IS MORE THAN 1 % (O5) WITH ANY IMPLANT WHICH IS CURRENTLY AVAILABLE ON THE MARKET. THOUGH IT IS ESTIMATED AS "HIGH RISK" THE DEVICES IN QUESTION ARE BEST STATE OF THE ART AND THERE ARE NO POSSIBILITIES FOR FURTHER MITIGATION OF THE RISK FROM A CLINICAL POINT OF VIEW. AS THE ITEM WAS NOT PROVIDED A MECHANICAL EXAMINATION OF THE BROKEN NAIL COULD NOT BE PERFORMED. WITH THE INFORMATION GIVEN A REASONABLE EXAMINATION AND INVESTIGATION WAS NOT POSSIBLE. WITH AVAILABLE INFORMATION A DEFICIENCY OF THE NAIL COULD NOT BE VERIFIED. THE FILE WILL BE CLOSED FORMALLY. IN CASE THE ITEM OR ANY OTHER SUBSTANTIVE INFORMATION SHOULD BECOME AVAILABLE, WE RESERVE THE RIGHT TO UPDATE THE INVESTIGATION AND CHANGE THE ROOT CAUSE. NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT RESPOND TO A STRYKER POST ABOUT HIP AND KNEE REPLACEMENTS. THE PATIENT STATED " I HAD A TOTAL RIGHT HIP REPLACEMENT WITH A STRYKER GAMMA 3. THE LEFT WAS REPAIRED WITH SCREWS. BOTH HIPS HAVE BEEN PAINFUL SINCE SURGERY". NEW INFORMATION: PATIENT REPORTED "FELL ON (B)(6) 2010. BROKE BOTH HIPS. WENT TO DR. (B)(6) 2010 FOR EXAM. ON (B)(6) 2010 MON. WENT TO HOSPITAL AT THE DIRECTION OF DR. WENT TO ((B)(6)). ON (B)(6) DR. (B)(6) OPERATED ON BOTH HIPS- RIGHT HIP GAMMA3 IMPLANT - LEFT HIP HE USED SCREWS. HOSPITAL STAY 1 WEEK. THERE HAS BEEN NO SURGERY SINCE (B)(6) 2010." IN ADDITION PATIENT REPORTED "THE PAIN IN MY HIPS HAVE BEEN THERE SINCE SURGERY. ONLY THE LOCATION AND SEVERITY CHANGES. AT TIMES THERE IS SOMETHING PINCHING SOMETHING. I AM LIMITED ON THE AMOUNT AND LENGTH OF TIME I CAN PERFORM TASKS." PATIENT PROVIDED LEFT HIP SCREW CATALOG/LOT CODE INFORMATION. SCREWS ARE NOT STRYKER PRODUCT.

    Description of Event or Problem · 1

    PATIENT RESPONDED TO A STRYKER POST ABOUT HIP AND KNEE REPLACEMENTS. THE PATIENT STATED " I HAD A TOTAL RIGHT HIP REPLACEMENT WITH A STRYKER GAMMA 3. THE LEFT WAS REPAIRED WITH SCREWS. BOTH HIPS HAVE BEEN PAINFUL SINCE SURGERY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290648 TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K271444

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention