Alteon 190-30-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862321084), received between Dec 8, 2020 and Jul 22, 2025 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 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 TOTAL HIP REPLACEMENT ON THE RIGHT SIDE. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A MEDIAL MIDLINE CRACK WITH STEM PLACEMENT. IT WAS NOTED THAT THE PATIENT WAS LIMITED TO 25-POUND WEIGHT BEARING FOR 2 WEEKS. NO MEDICAL INTERVENTION AND NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 22570532 ↗
• InjuryDec 1, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS (B)(6) FEMALE PATIENT PRESENTED WITH PAIN AND UPON REEXAMINATION LEFT HIP ALTEON STEM APPEARED LOOSE PROXIMALLY. EVENT DATE UNKNOWN. APPROXIMATELY 6 MONTHS PRIOR TO AWARE DATE. PATIENT WAS REVISED TO COMPETITOR IMPLANTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant

  MAUDE report 12909820 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, DURING THE INITIAL IMPLANTATION OF A THA, ON THIS FEMALE PATIENT AFTER COUNTERSINKING A SIZE 6 BROACH IN THE PATIENT'S FEMORAL CANAL THE SURGEON ASKED FOR A SIZE 6 COLLARED STEM. WHILE ATTEMPTING TO SEAT THE IMPLANT TO REPRODUCE THE POSITION OF THE BROACH THE PATIENT'S FEMUR CRACKED. HE THEN EXTRACTED THE IMPLANT, APPLIED CABLES TO THE FEMUR AND WENT THROUGH EXTENSIVE BROACHING AND RE-BROACHING TO GET THE IMPLANT TO FIT. THIS CAUSED 30-45 MINS DELAY IN SURGERY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES NOT RETURNING, IT IS IMPLANTED INTO THE PATIENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 10972479 ↗

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