MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 30600090S

Device Problem Insufficient Information (3190)

Patient Problems Necrosis (1971); Pain (1994)

Event Date 12/06/2014

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Event Description

Patient had a short gamma nail implanted somewhere in (b)(6) for a femoral neck fracture.She went on to heal successfully.No information is available from the original surgery.Patient came to see dr.With hip pain.He determined that she had developed avn.She was scheduled for a revision and conversion to a total hip.That procedure was completed successfully.

Manufacturer Narrative

Evaluation revealed the trochanteric nail kit, the lag-, locking-, and set screw to be the primary products.No further associated products were reported.A physical examination could not be carried out as the devices were not returned for evaluation (hospital policy).A review of the device history records could not be carried out as the lot codes were unknown and not provided except for the lag screw, which was documented as faultless prior to distribution.Further information such as x-rays, medical records or surgery reports will not be provided due to hospital policy.Thus, a reasonable examination and investigation was not possible.In the case presented a patient had been treated with a trochanteric nail on (b)(6) 2014 due to a femoral neck fracture.According to information received the patient went on to heal successfully.Two years later the patient was re-admitted to a hospital as she was experiencing pain in her hip.The attending physician determined that the patient was developing an avascular necrosis.The patient was revised on (b)(6) 2016, where the gamma3 implants were removed and replaced by a total hip arthroplasty.Avascular necrosis is known and nominated in the medical science / scientific literature.It is defined as the death of bone tissue due to a lack/ insufficient or interruption of the blood supply.This can lead to a collapse of the bone structures, which might result in bone destruction, pain or loss of the joint function.Although the pathophysiology is not fully understood yet, it is agreed that the interruption of the blood flow to the bone is the root cause.Several potential causes of avascular necrosis and other health conditions are associated with its development, which for example are direct trauma (e.G.Fracture or dislocation), steroid medications, excessive alcohol use and other risk factors (e.G.Radiation therapy, chemotherapy, organ transplantation,¿) a correlation to the initial femoral neck fracture treatment (nail insertion procedure and / or fracture healing) cannot be excluded.Nevertheless avascular necrosis is primarily not associated or contributed by the implants.With available information a deficiency of the affected implants could not be verified.A more precise evaluation was not possible based on the information given.Based on the above the event was most likely caused by the patient¿s condition and / or by the surgical technique, but not caused by a deficiency of the devices.The file will be closed formally.In case relevant clinical information or the items should become available, we reserve the right to update the investigation and change the root cause.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.

Event Description

Patient had a short gamma nail implanted somewhere in (b)(6) for a femoral neck fracture.She went on to heal successfully.No information is available from the original surgery.Patient came to see dr.With hip pain.He determined that she had developed avn.She was scheduled for a revision and conversion to a total hip.That procedure was completed successfully.

• Brand Name: LAG SCREW, TI GAMMA3® Ø10.5X90MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6201109
• MDR Text Key: 63187788
• Report Number: 0009610622-2016-00641
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 30600090S
• Device Lot Number: K025C33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 63