Alteon 190-30-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862321138), received between Jul 10, 2025 and Jul 10, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Implant subsidence” (1 report).

1 other recall cover devices cleared under the same FDA submission (K162732); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Implant subsidence; Implant subsidence

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT THA. SUBSEQUENTLY, THE PATIENT REPORTED HAVING ANTERIOR HIP GROIN AND THIGH PAIN. THE SURGEON SUSPECTED STEM SUBSIDENCE. AS A RESULT, THE PATIENT RECEIVED AN ESI 22 MONTHS AFTER INITIAL IMPLANTATION. SEVERE LUMBAR STENOSIS WAS ALSO NOTED BY THE SURGEON AT THE 2 YEAR FOLLOW-UP. THIS EVENT WAS REPORTED TO BE RESOLVED. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain; Stenosis

  MAUDE report 22470217 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162732. One submission often covers many models, so check the product and lot details in each record.

• Z-0538-2018 · Oct 9, 2017 · Terminated
  Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals underg