Alteon 190-31-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862320933), received between Nov 14, 2023 and May 30, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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.

• InjuryMay 30, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 7 MONTHS POST INITIAL OPERATION. SUBSEQUENTLY, THE PATIENT'S STEM BECAME LOOSE CAUSING PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22113875 ↗
• InjuryNov 14, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED DURING A MEETING BETWEEN A SURGEON AND A MEMBER OF EXACTECH¿S HIP TEAM THAT THE SURGEON HAD CASES BEING CLINICALLY MONITORED FOR POTENTIAL LOOSENING BASED ON LUCENCIES SEEN IN FOLLOW-UP RADIOGRAPHS. POST-OPERATIVE AND FOLLOW-UP RADIOGRAPHS WERE SUBSEQUENTLY PROVIDED FOR A TOTAL OF 10 CASES. IN THIS CASE, A 67 YEAR OLD MALE WAS REPORTED FOR CONCERNS OF POSSIBLE FEMORAL STEM LOOSENING BASED UPON 1 YEAR FOLLOW UP RADIOGRAPHS. AT THE TIME OF REPORTING, THE PATIENT WAS OVER 1.5 YEARS POST SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING HIS CLINICAL HISTORY, SYMPTOMS, OR ONGOING TREATMENT. PATIENT HAS HISTORY OF THA ON THE CONTRALATERAL SIDE. ADDITIONAL INFORMATION - AS REPORTED VIA LEGAL DOCUMENTATION THIS PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY IMPLANT (B)(6) 2018 AND THEN APPROXIMATELY 4 YEARS LATER ON (B)(6) 2022 THE PATIENT EXPERIENCED A REVISION SURGERY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER CURRENT IMAGES OF THE DEVICE PROVIDED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 18136676 ↗

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