Alteon 01-030-02-0552Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862549341), received between Oct 4, 2021 and Oct 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K182502); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2021Device-Device Incompatibility; Loosening of Implant Not Related to Bone-Ingrowth; Device-Device Incompatibility; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 1 MONTH POSTOP THE IMPLANTATION OF THIS HIP, ON (B)(6) 2021 THE SURGEON REMOVED THE ALTEON CUP BECAUSE IT NEVER ACHIEVED INITIAL FIXATION. HE CONVERTED TO A DUAL MOBILITY SMITH AND NEPHEW CUP AND A NEW EXACTECH FEMORAL HEAD. IT WAS NOTED THAT ADDITIONAL SCREWS HELPED ACHIEVE FIXATION THIS TIME. NO ADDITIONAL INFORMATION AVAILABLE INCLUDING XRAYS OR EXPLANTS. ADDITIONAL INFORMATION RECEIVED INDICATES AFTER FIRST REVISION RELATED TO THIS CASE, PATIENT FOLLOWED UP WITH PAIN AND X-RAY REVEALED THE CUP HAD MOVED AND COME LOOSE. SURGEON FELT HE MAY HAVE NEEDED MORE THAN THE 2 SCREWS HE USED WITH THE ALTEON MULTI HOLE CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12571777 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182502. One submission often covers many models, so check the product and lot details in each record.

• Z-1167-2025 · Dec 31, 2024 · Open, Classified
  Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G22
• Z-0578-2024 · Nov 21, 2023 · Open, Classified
  Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536