MAUDE Adverse Event Report: H-MAX S STEM; H-MAX S STEM - STANDARD - TAPER 12/14 #13 H.155MM

Model Number	4250.20.130
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of dhrs of lot number 2213329 did not highlight any pre-existing anomalies.This is the first and only complaint received on this lot number.A final report will be submitted after the investigation is completed.
Event or Problem Description
The complaint source reported that during a hip surgery an intraoperative periprosthetic fracture occurred that required osteosynthesis with cerclage wires.The outcome of the surgery was satisfactory: after one year no sign of dislocation/loosening/fracture.Fracture healed without any further complications in few months.Patient is without symptoms and walks without any aids.The implanted devices during the procedure are: h-max s standard fem.Stem #13 (product code: 4250.20.130, lot: 2213329 - ster: (b)(4)).Fem.Modular head - l ø28mm (product code: 5010.09.283, lot: 2223627 - ster: (b)(4)).Lock bipol.Self-cent.Head ø52 (product code: 5527.09.520, lot: 2118970 - ster: (b)(4)).The complaint was received by our clinical department as an sae reported as part of a clinical study.The event was assessed by the hospital's clinical study team and was considered not related to the medical device, but to the surgical procedure.The fracture was most likely related to the limited experience of the surgeon in training with uncemented stems in the elderly population.The event occurred in slovenia.

• Brand Name: H-MAX S STEM
• Common Device Name: H-MAX S STEM - STANDARD - TAPER 12/14 #13 H.155MM
• MDR Report Key: 24911465
• Report Number: 3008021110-2026-00190
• Device Sequence Number: 9067510
• Product Code: KWY
• UDI-Device Identifier: 08033390298926
• UDI-Public: 08033390298926
• Combination Product (Y/N): N
• PMA/510(K) Number: K160011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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
• Device Model Number: 4250.20.130
• Device Catalogue Number: 4250.20.130
• Device Lot Number: 2213329
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/17/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown