Alteon 188-00-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862250773), received between Mar 15, 2023 and Mar 24, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

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.

• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY TWENTY-SIX DAYS POST INITIAL RIGHT THA, THE 69 Y/O FEMALE PATIENT WAS BROUGHT BACK FOR RIGHT HIP PAIN. SALES REP WAS UNAWARE IF PATIENT FELL OR HAD ANY TYPE OF TRAUMA TO THE HIP. SHE FRACTURED HER LESSER TROCH. THE HIP WAS DISLOCATED, THE FEMORAL HEAD AND STEM REMOVED. THE FRACTURE WAS REDUCED WITH THE USE OF A CABLE SYSTEM. THE POLY LINER WAS REMOVED WITH THE HELP OF A BONE SCREW. A NEW G4 ALTEON 36MM LINER WAS IMPLANTED AND A LONG SMITH AND NEPHEW HIP STEM WAS CEMENTED IN PLACE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOW TO BE INSTABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND X-RAY RECEIVED, THE DEVICES ARE AVAILABLE FOR EVALUATION.

  Patient problems: Pain; Periprosthetic fracture

  MAUDE report 16613004 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  INFORMATION FOUND DURING THE INVESTIGATION OF A LEGAL COMPLAINT; THAT THE 58-YEAR-OLD FEMALE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION OF RIGHT FEMUR FOR PERIPROSTHETIC FRACTURE ON (B)(6) 2017 , APPROXIMATELY 3 MONTHS POST INITIAL IMPLANT PROCEDURE. SURGEON¿S PREOPERATIVE DIAGNOSIS WAS CONFIRMED DURING SURGICAL REVISION. NO EVIDENCE OF INFECTION PER THE REVISION OPERATIVE REPORT. ROUTINE CULTURES WERE MADE. GRAM STAINS WERE CLEAR. SURGEON NOTED, "THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION HAVING TOLERATED THE PROCEDURE WELL." NO DEVICE RETURN IS ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO IMAGES OR X-RAYS PROVIDED. NO OTHER PATIENT OR MEDICAL INFORMATION IS PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Bone Fracture(s); Hip Fracture

  MAUDE report 16549548 ↗