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

Model Number 627644

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Range of Motion (2032); Non-union Bone Fracture (2369); Implant Pain (4561)

Event Date 05/19/2023

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : hospital retained device.

Event Description

It was reported that the patient's right femur was revised.After a previous orif to address a femoral fracture, patient presented complaining of pain and limited rom.X-ray showed non-union of the bone with 3 broken screws and one screw which pulled out with the plate.A femoral stem and head, the plate and screws, and a competitor knee were revised to a competitor total femur replacement (acetabular components were left in situ).Rep confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Please note the correction to b1.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.An x-ray was provided which were presented to our health care professional for evaluation, and a question about the most likely reason for this event, to which the medical expert replied: ¿it is likely to be related to a failure in stability from the entire construct leading to the non-union.I can say some things about the construction.Proximal screws are missing in the construction.However, since i don¿t have the trauma x-rays, the post-operative pics, etc., so there is no complete picture.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

It was reported that the patient's right femur was revised.After a previous orif to address a femoral fracture, patient presented complaining of pain and limited rom.X-ray showed non-union of the bone with 3 broken screws and one screw which pulled out with the plate.A femoral stem and head, the plate and screws, and a competitor knee were revised to a competitor total femur replacement (acetabular components were left in situ).Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR RIGHT FEMUR 14 HOLE / L310MM
• Type of Device: 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: 17124169
• MDR Text Key: 317116523
• Report Number: 0008031020-2023-00229
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613252579687
• UDI-Public: 07613252579687
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222381
• 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: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 627644
• Device Catalogue Number: 627644
• Device Lot Number: H24832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 84 KG