Alteon 190-11-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862321664), received between Jul 2, 2025 and Jul 22, 2025 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionJul 22, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT THA APPROXIMATELY 4 YEARS AGO. DURING THE PROCEDURE, IT WAS NOTED THAT THE SURGEON "COULD NOT GET SIZE 2 STEM DOWN ANY FURTHER". NO HARM OR INTERVENTION HAS BEEN REPORTED AS A RESULT OF THIS MALFUNCTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22570533 ↗
• InjuryJul 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 26 MONTHS MONTH AFTER A LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT COMPLAINED OF PAIN. THE PATIENT WAS REVISED DUE TO THE STEM BEING LOOSE. THE SURGEON USED A COMPETITOR'S STEM AND AN EXACTECH LINER. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22385429 ↗

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