Alteon 190-30-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862321060), received between Oct 14, 2020 and Jul 22, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT THA APPROXIMATELY 4 YEARS AGO. DURING INITIAL SURGERY THE SURGEON NOTED "MEDIAL CALCAR CRACK DURING STEM INSERTION. CONSIDERED CABLE". NO INTERVENTION OR FURTHER PATIENT IMPACT WAS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 22570558 ↗
• InjuryOct 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 34 MONTHS POSTOP THE INITIAL LEFT THA, THIS (B)(6) Y/O FEMALE PATIENT¿S LEFT HIP STEM WAS REVISED DUE TO LOOSENING. THE HEAD WAS REMOVED AND THE POLY FOR THE CUP WAS REMOVED TO CHECK IF THE CUP WAS WELL FIXED. A NEW NOVATION LINER WAS IMPLANTED AND THE PATIENT RECEIVES AN EXACTECH MONOBLOC STEM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES TO BE RETURNED. RG PENDING.

  Patient problems: Failure of Implant

  MAUDE report 10676971 ↗

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