Alteon 190-21-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862321220), received between Apr 26, 2021 and Sep 19, 2023 — 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.

• InjurySep 19, 2023Unintended Movement; Migration; Unintended Movement; Migration

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT THA ON (B)(6) 2023 AND HAS SINCE SUBSIDED. THE PATIENT WAS REVISED ON (B)(6) 2023 AND IMPLANTED WITH COMPETITOR'S DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 17774912 ↗
• InjuryApr 26, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, A REVISION DUE TO A BONE FRACTURE AND FEMORAL LOOSENING WAS COMPLETED. THERE IS CONCERN THAT THE HA COATING MAY BE DELAMINATING. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME

  Patient problems: Failure of Implant

  MAUDE report 11729485 ↗

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