Alteon 190-00-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862514646), received between May 3, 2021 and May 3, 2021 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS (B)(6) Y/O FEMALE PATIENT¿S PRIMARY RIGHT THA WAS PERFORMED 15 MONTHS AGO. AT SOME POINT THE FEMORAL STEM BECAME LOOSE AND FELL INTO VARUS. THE REVISION WAS PERFORMED ANTERIORLY. THE ALTEON HA WAS GROSSLY LOOSE AND WAS ABLE TO BE REMOVED BY HAND. PATIENT WAS REVISED TO A NOVATION PF SPLINED STEM STANDARD OFFSET SIZE 12 AND A 32MM +0MM BIOLOX DELTA HEAD. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 11761640 ↗

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