Alteon 190-31-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862320957), received between Dec 15, 2020 and Jun 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 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.

• InjuryJun 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 LEFT THA . SUBSEQUENTLY, THE PATIENT EXPERIENCED LOOSENING OF THE FEMORAL STEM. AS A RESULT, THE PATIENT UNDERWENT A LEFT HIP REVISION SURGERY APPROXIMATELY 8 MONTHS AFTER INITIAL IMPLANTATION WHERE THE ACETABULAR LINER WAS EXCHANGED TO A LIPPED ACETABULAR LINER. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 22307683 ↗
• InjuryDec 15, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 41 MONTHS POSTOP THIS (B)(6) MALE PATIENT¿S LEFT HIP THE PATIENT WAS REVISED DUE TO LOOSENING. PT HAS HISTORY OF OSTEOARTHRITIS. THE HEAD WAS REMOVED, THE STEM WAS REMOVED, AND THE POLY LINER WAS REMOVED TO CHECK THE CUP. THE CUP WAS WELL FIXED, THE PATIENT RECEIVED A NEW LINER, A NEW MONOBLOC STEM, AND A NEW BIOLOX HEAD. THE PATIENT RECEIVED A NEW 40MM LINER LIPPED INSERT, A 19X245 MONOBLOC STEM WITH A 40 +7 BIOLOX HEAD. DEVICES ARE RETURNING. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 11006311 ↗

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