Alteon 190-20-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862321824), received between Jun 8, 2020 and Mar 1, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (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 16, 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.

• InjuryMar 1, 2023Positioning Failure; Migration; Positioning Failure; Migration

  IT WAS REPORTED A 60 YO MALE PATIENT, INITIAL RIGHT HIP IMPLANTED ON (B)(6) 2022, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 5 MONTHS POST THE INITIAL PROCEDURE. THE STEM SUBSIDED SOMETIME AFTER THE INITIAL SURGERY AND HAD TO BE REVISED. THE ORIGINAL STEM AND HEAD WERE REMOVED AND REPLACED WITH LARGER SIZES. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PRODUCT RETURNING AS THE PATIENT WANTED IT. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 16465025 ↗
• InjuryJun 8, 2020Migration; Migration

  AS REPORTED, A RIGHT PRIMARY ANTERIOR TOTAL HIP WAS PERFORMED ON A (B)(6) FEMALE PATIENT. APPROXIMATELY 11 DAYS POSTOP, DURING PHYSICAL THERAPY, THE PATIENT EXPERIENCED SHARP PAIN AND WAS ADMITTED TO THE HOSPITAL, THE STEM HAS SUBSIDED, AND THE FEMUR POSSIBLY HAS FRACTURED. REVISION OF THE FEMUR IS SCHEDULED FOR NEXT WEEK. NO FURTHER INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 10131330 ↗

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