MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR RIGHT FEMUR 14 HOLE / L310MM; PLATE, FIXATION, BONE

Catalog Number	627644
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that: the patient had a fracture on a knee prosthesis in (b)(6) 2023 operated with an axsos femur plate.She fell at home and broke her axsos plate.The patient required a revision surgery with a new axsos femur plate and bone graft.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.With available radiographs a formal medical opinion was sought: the x-rays confirm the indication.The patient had a periprosthetic fracture proximal from a total knee replacement.The fracture is a spiral fracture, typically cause by a rotational force fracturing the bone.There was comminution of the fracture and an anatomical reposition and fixation was performed.The fixation was done by a bridging technique, meaning no screws were placed in the plate in the fracture area, just screws proximally and distally of the fracture.The fracture zone was further stabilized with 6 cable grips.One of the fracture lines extended distally into the distal femoral condylar area.At three months postoperatively there is periosteal bone formation, however no full consolidation yet.Assessing the timeline, the chosen fixation method, and the breakage of the plate, i conclude that this plate fracture most likely resulted from the patient¿s fall.But with the available information no conclusive statement can be provided, because key clinical information (e.G., clinical status, exact symptoms, and range of motion of the patient, weight-bearing protocol assessment of the treating physician) is missing.The root causes of radiographic findings are often complex and multifactorial and cannot be determined scientifically without this decisive evidence.Due to these limitations, i am unable in such cases to provide definitive statements about the patient, the procedure and/or the device in relation to cause of the failure.¿ the received distal lateral femur plate axsos 3 for right femur was visually analyzed and we can see that the plate is broken into two fragments, after analyzing the broken surface of the distal and proximal end, and both the alternate sides right and left of broken surface.It can be stated that the breakage is a combination of fatigue and brittle in nature.The fatigue breakage is confirmed with shinny surface and fatigue line which are diminished with rubbing of two surface before complete breakage, rubbing can also be confirmed with edges of the plate as they are completely deformed out of shape.On the other end we can have mountain type surface of breakage which indicate towards a brittle fracture caused by sudden fall.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.In this relation following statement of the axsos 3 implants instructions for use can be mentioned: ¿the implant is intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.Regular postoperative examinations (e.G.X-ray checks) are advisable.¿ [original statements] no indications of material, manufacturing or design related problems were found during the investigation.Based on the above investigation, the root cause can be attributed to patient-related factors.The component could not withstand the force applied by the patient over time, resulting in fatigue and ultimately breakage when the patient fell.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that: "the patient had a fracture on a knee prosthesis in (b)(6) 2023 operated with an axsos femur plate.She fell at home and broke her axsos plate.The patient required a revision surgery with a new axsos femur plate and bone graft.".

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR RIGHT FEMUR 14 HOLE / L310MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19225062
• Report Number: 0008031020-2024-00188
• Device Sequence Number: 17873366
• Product Code: HRS
• UDI-Device Identifier: 07613252579687
• UDI-Public: 07613252579687
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K222381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 627644
• Device Lot Number: K70510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 70 KG