Alteon 190-31-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862320926), received between Nov 20, 2020 and Mar 8, 2022 — 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.

• InjuryMar 8, 2022Migration; Migration

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL RIGHT SIDE THA, THIS MALE PATIENT WAS REVISED DUE TO OSTEOLYSIS AND THE STEM WAS ALSO SUBSIDED. PATIENT RECEIVED DEPUY IMPLANTS. THERE WAS NO BREAKAGE OF DEVICE AND NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS OR X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL KEEP THE IMPLANTS.

  Patient problems: Failure of Implant

  MAUDE report 13690659 ↗
• InjuryNov 20, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY I YEAR POSTOP THE INITIAL THA, THIS FEMALE PATIENT WAS REVISED DUE TO A LOOSE STEM. THE COCR HEAD WAS REMOVED AFTER DISLOCATING, THE STEM WAS REMOVED, THE POLY LINER WAS REMOVED TO CHECK THE CUP, A NEW POLY WAS IMPLANTED, AND A MONOBLOC STEM WAS RE-IMPLANTED ALONG WITH A NEW HEAD. THE PATIENT RECEIVED A NEW LINER, A 16X245 MONOBLOC, WITH A NEW HEAD. THE PATIENT APPEARED TO HAVE PRIOR OSTEOARTHRITIS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES TO BE RETURNING.¿

  Patient problems: Failure of Implant

  MAUDE report 10874660 ↗

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