MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 10 HOLE / L238MM; PLATE, FIXATION, BONE

Catalog Number 627640

Device Problems Break (1069); Fracture (1260)

Patient Problems Pain (1994); Depression (2361); Ambulation Difficulties (2544)

Event Date 10/27/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that stryker plate broke in half causing excruiating pain and a second surgery.Because this plate broke almost one year to the day of the fist surgery i lost another year due to additional surgery, wheel chair bound, physical therapy, depression because of faulty plate.

Manufacturer Narrative

The reported event could be confirmed, based on pictures and x-rays provided.Based on the investigation, the root cause was attributed to be patient related.The failure was caused by overloading of the plate due to non-union of the bone.Pictures were provided for evaluation, and indeed, the plate is broken in two pieces at the level of the middle hole of the plate.The surface of the plate is scratched, most likely caused during contouring, implantation and/or explantation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.General aspects: the correct selection of the fracture fixation appliance is extremely important.Failure to use the appropriate appliance for the fracture condition may accelerate clinical failure.Failure to use the proper component to maintain adequate blood supply and provide rigid fixation may result in loosening, bending, cracking or fracture of the device and/or bone.The correct implant size for a given patient can be determined by evaluating the patient¿s height, weight, functional demands and anatomy.Every implant must be used in the correct anatomic location, consistent with accepted standards of internal fixation.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.

Event Description

It was reported that stryker plate broke in half causing excruiating pain and a second surgery.Because this plate broke almost one year to the day of the fist surgery i lost another year due to additional surgery, wheel chair bound, physical therapy, depression because of faulty plate.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 10 HOLE / L238MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8287411
• MDR Text Key: 134443451
• Report Number: 0008031020-2019-00053
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613252579663
• UDI-Public: 07613252579663
• Combination Product (y/n): N
• PMA/PMN Number: K181091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 627640
• Device Lot Number: V13190
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 66