MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 FOR RIGHT HUMERUS 8 HOLE / L151MM; PLATE, FIXATION, BONE

Catalog Number	627238S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
Revision of implant - due to stem positioning post peri prosthetic fracture - previous plate was removed and the stem was removed and replaced with a longer one.Revision date: (b)(6) 2025.
Additional Manufacturer Narrative
Correction - please refer d1 product long description, d2a common device name, d3 manufacturer entity, d4 cat & lot, g1 manufacturing site, fda registration - sel (8031020) the received x-ray was reviewed and the reported periprosthetic fracture of the proximal humerus can be confirmed.A device inspection was not possible since the affected device was not returned, therefore no further evaluation was possible.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.Since an x-ray was provided, the opinion of a medical expert was sought and stated as follows- the image confirms the varus malalignment and periprosthetic fracture of the proximal humerus due to foregoing events (of which there are no details available).The proximal humerus is deformed into varus (angulated in a medial direction).All implant components are intact, and there are no signs of joint instability.Since there are no earlier-in-time images to compare with, the events leading to this current situation cannot be assessed.In case of a revision procedure a medical opinion aiming to determine the root cause of the failure is part of the internal investigation process.Sufficient (radiological and clinical) information must be provided to enable a meaningful clinical assessment and to identify possible causes of failure.In cases where no such information is available, this assessment is limited.No conclusive statement can be provided, because key clinical information (e.G.Clinical status, exact symptoms and range of motion of the patient, assessment of the treating physician) is missing.Due to these limitations, i am unable to provide statements about the patient, the procedure, and/or the device in relation to cause of the failure.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.In general it can be stated that peri-prosthetic fractures are not indicated for the axsos 3 proximal lateral humerus plates and that the reported plate/stem combination can be considered as off-label use for the axsos 3 proximal lateral humerus plate system.However, in retrospective it cannot be defined what role the combination of the devices did finally play.Per axsos 3 implants instruction for use (v15300 rev.Ab, 09-2023) are the indications- the axsos 3 proximal lateral humerus plates are indicated for diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures; non-unions; malunions and osteotomies in the proximal humerus.If more information is provided, the case will be reassessed.
Event or Problem Description
Revision of implant - due to stem positioning post peri prosthetic fracture - previous plate was removed and the stem was removed and replaced with a longer one.Revision date: (b)(6) 2025.

• Brand Name: PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 FOR RIGHT HUMERUS 8 HOLE / L151MM
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21812382
• Report Number: 3000931034-2025-00185
• Device Sequence Number: 7307027
• Product Code: HRS
• UDI-Device Identifier: 07613327091335
• UDI-Public: (01)07613327091335(17)240731(10)D39852
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2024
• Device Catalogue Number: 627238S
• Device Lot Number: D39852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2019
• 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: 69 YR
• Patient Sex: Male