Alteon 190-30-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862321053), received between Apr 15, 2022 and Jul 23, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryJul 23, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL HIP REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN SECONDARY TO FEMORAL LOOSENING. AS A RESULT, APPROXIMATELY FOUR YEARS AND ONE-MONTH POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22575837 ↗
• InjuryApr 15, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL LEFT THA, THIS (B)(6) FEMALE PATIENT WAS BROUGHT BACK FOR LEFT HIP PAIN DUE TO A LOOSE STEM. THE HIP WAS DISLOCATED, THE FEMORAL HEAD WAS REMOVED, ATTENTION TURNED TO THE CUP, THE LINER WAS REMOVED WITH THE HELP OF AN OSTEOTOME, THE CUP WAS CHECKED AND FOUND TO BE WELL FIXED. A NEW XLE G1 LIPPED LINER WAS IMPLANTED. THE STEM WAS CHECKED, FOUND TO BE LOOSE AND REMOVED. A NEW STEM AND HEAD WAS THEN IMPLANTED. PATIENT WAS REVISED TO XLE G1 32MM LIPPED INSERT, A STD 7 TAPER WEDGE STEM AND A 32++0 BIOLOX HEAD. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14117992 ↗

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