Alteon 190-31-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862320940), received between Aug 24, 2021 and Aug 24, 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. How this data works · Data updated Oct 13, 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.

• InjuryAug 24, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE (B)(6) MALE PATIENT¿S STEM WAS REVISED DUE TO LOOSENING. THE HIP WAS DISLOCATED, FEMORAL HEAD REMOVED, STEM WAS FOUND TO BE LOOSE AND REMOVED, ATTENTION TURNED TO THE CUP, LINER WAS REMOVED CUP WAS FOUND TO BE WELL FIXED. A NEW LINER WAS PLACED, AND THE PATIENT RECEIVED A NEW 16X245 MONOBLOC STEM AND BIOLOX HEAD. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED DUE TO THE HOSPITAL DISCARDED THE IMPLANTS.

  Patient problems: Failure of Implant

  MAUDE report 12362448 ↗

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