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

Model Number	627640
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Limb Fracture (4518)
Date of Event	02/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a peri prosthetic fracture case.The patient had previously had a fracture plated with an axsos distal lateral femur plate but the plate has now broken.The patient had to be revised.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the product returned is broken in two at the level of the 7th screw hole.Signs of a fatigue fracture are visible with the microscopic analysis of the broken area.This gives evidence that the fracture was caused by repeated overloading of the plate.Based on investigation, the root cause was attributed to a patient related issue.The failure was probably caused by repeated overloading of the plate.A probable poor bone condition, related to the advanced age of the patient (91 years old) is likely to have influenced a poor recovery and the fracture of the device.It was reported that the patient ¿apparently did dance¿, thus the patient was active and did not fully respect the recovery time advised (the reported fracture occurred 2 months after implantation).This supports the conclusion that the fracture was caused by fatigue of the plate.In order to have a more complete conclusion as of the patient¿s bone condition, x-rays of the fracture would be required.As a reminder, the ifu clearly states: " the surgeon must warn the patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or nonunion and that the device has a finite expected service life and may need to be removed at some time in the future.[.] these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason post-operative instructions and warnings to patients are extremely important.External immobilization (e.G.Bracing or casting) may be employed until x-rays or other procedures confirm adequate bone consolidation." 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.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported a peri prosthetic fracture case.The patient had previously had a fracture plated with an axsos distal lateral femur plate but the plate has now broken.The patient had to be revised.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR RIGHT FEMUR 10 HOLE / L238MM
• Common Device Name: SCREW, 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: 13727660
• Report Number: 0008031020-2022-00097
• Device Sequence Number: 4623369
• Product Code: HWC
• UDI-Device Identifier: 07613252579663
• UDI-Public: 07613252579663
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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 Expiration Date: 09/30/2022
• Device Model Number: 627640
• Device Catalogue Number: 627640
• Device Lot Number: L34466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2017
• 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 Sex: Male