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

Model Number	627644
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• 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: 17124169
• Report Number: 0008031020-2023-00229
• Device Sequence Number: 17773097
• Product Code: HRS
• UDI-Device Identifier: 07613252579687
• UDI-Public: 07613252579687
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K222381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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 Model Number: 627644
• Device Catalogue Number: 627644
• Device Lot Number: H24832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 84 KG