H-MAX S Stem 4250.20.130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390298926), received between Feb 18, 2026 and Apr 17, 2026 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Bone Fracture(s)

  MAUDE report 24911465 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2026 DUE TO INFECTION. THE PREVIOUS SURGERY WAS DONE ON (B)(6) 2024. THE FOLLOWING DEVICES WERE EXPLANTED: LINER #L FOR MOBILE LINER Ø42 (PRODUCT CODE: 5885.09.042, LOT: 2307316 - STER: 2300105). MOBILE LINER ØINT 28 MM Ø42 MM (PRODUCT CODE: 5566.54.420, LOT: 23AT2B0 - STER: 2300202). FEM. MODULAR HEAD - S Ø28MM (PRODUCT CODE: 5010.42.281, LOT: 7011770046). DELTA-TT ACETAB.CUP Ø56 MM (PRODUCT CODE: 5552.15.560, LOT: 2413576 - STER: 2400143). H-MAX S STANDARD FEM.STEM #13 (PRODUCT CODE:4250.20.130, LOT: 2318969 - STER: 2300205). EVENT OCCURRED IN ITALY.

  Patient problems: Medical device site infection

  MAUDE report 24377827 ↗