Alteon 190-30-08 (UDI 10885862321107)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862321107), received between Sep 21, 2020 and Oct 15, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2024Use of Device Problem; Migration; Use of Device Problem; Migration

  AS REPORTED, THE PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY (THA) PERFORMED. POSTOPERATIVELY, IN RECOVERY, X-RAYS SHOWED THE FEMORAL STEM COMPONENT EXITING THROUGH THE POSTERIOR FEMORAL CANAL WALL. THE STEM WAS NOT IN POSITION. THE PATIENT WAS SCHEDULED FOR A REVISION THA AND FEMORAL STEM REMOVAL AND REIMPLANTATION OF A MONOBLOCK FEMORAL HIP STEM. THE PATIENT WAS REVISED AND THE FEMORAL HEAD AND STEM WERE REMOVED AND A MONOBLOCK STEM AND FEMORAL HEAD WERE IMPLANTED AND CONFIRMED ON X-RAY INTRAOPERATIVELY. THERE WAS NO REPORTED BREAKAGE OF A DEVICE AND 15-30 MINUTE DELAY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450507 ↗
• InjuryMar 29, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 1 YR. POSTOP THE INITIAL R TSA, THIS (B)(6) PATIENT'S RIGHT SHOULDER WAS REVISED DUE TO LOOSENING OF THE FEMORAL STEM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL RETURN DUE TO FACILITY POLICY.

  Patient problems: Failure of Implant

  MAUDE report 11586207 ↗
• InjuryDec 22, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 11 MONTHS POSTOP THE INITIAL LEFT THA. THIS (B)(6) Y/O MALE WITH A HISTORY OF OSTEOARTHRITIS, WAS REVISED. THE PATIENT RECEIVED A NEW XLE 40MM LIPPED LINER, A 19X245 MONOBLOC AND A 40MM +10 HEAD. DEVICES NOT RETURNING. THE PATIENT REQUESTED THE IMPLANTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 11060999 ↗
• InjurySep 21, 2020Migration; Migration

  AS REPORTED, APPROXIMATELY 1 YEAR POSTOP THE INITIAL THA, THIS (B)(6) MALE, PATIENT WAS REVISED. THE STEM SUBSIDED LATERALLY AND BECAME LOOSE WITHIN PATIENT, CAUSING PAIN AND DISCOMFORT. THE ALTEON HA STEM THAT WAS LOOSE AND TAKEN OUT WAS A 36MM -3.5 OFFSET BIOLOX HEAD. THE SURGEON PUT IN A MONOBLOC STEM AND NEW 36MM +0 OFFSET BIOLOX HEAD. THE ZB G7 CUP AND LINER WAS LEFT IN THE HIP. THE SURGEON USED A COMBINATION OF EXACTECH/ZB ON INITIAL SURGERY DATE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT RETURN AS HOSPITAL DISPOSED OF THEM.

  Patient problems: Failure of Implant

  MAUDE report 10564160 ↗

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