Alteon 190-31-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862320964), received between Feb 11, 2021 and Dec 30, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY LEGAL NOTIFICATION, APPROXIMATELY 5 YEARS AND 3 MONTHS POST THE INITIAL RIGHT TOTAL HIP REPLACEMENT, THE PATIENT WAS REVISED DUE TO POSSIBLE FEMORAL LOOSENING. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21036852 ↗
• InjuryMay 26, 2022Migration; Migration

  AS REPORTED, THE (B)(6) MALE PATIENT HAD A REVISION DUE TO STEM SUBSIDENCE. PATIENT WAS REVISED WITH A ZB STEM, CUP WAS RETAINED AND A NEW LINER WAS IMPLANTED. THERE WAS NO BREAKAGE OF A DEVICE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND X-RAYS RECEIVED. PRODUCT WILL NOT BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 14519116 ↗
• InjuryFeb 11, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 3 YEARS AFTER THE INITIAL THA, THE (B)(6) Y/O MALE PATIENT¿S RIGHT HIP DISLOCATED AND WAS REVISED DUE TO LOOSENING OF THE STEM. THE FEMORAL HEAD WAS REMOVED. THE STEM WAS CHECKED AND FOUND TO BE LOOSE. THE STEM WAS REMOVED. THE LINER WAS REMOVED, AND THE CUP WAS CHECKED. IT WAS FOUND TO BE WELL FIXED. A NEW LINER WAS IMPLANTED. THE PATIENT ALSO RECEIVED A NEW STEM AND HEAD. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WERE NOT SAVED BY THE FACILITY. CONCOMITANT DEVICES: (CN: 138-36-52, SN: (B)(4)) - NV GXL LNR, 10 DEG FACE, 36MM ID, GRP 2 CUP. (CN: 170-36-00, SN: (B)(4)) - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM.

  Patient problems: Failure of Implant

  MAUDE report 11314297 ↗

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