ABG 4845-0104Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327050950), received between Sep 30, 2021 and Nov 30, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2022Fracture; Fracture

  ON (B)(6) 2022 IN A PATIENT WAS ADMITTED TO THE SURGICAL AND ORTHOPEDIC WARD AS AN EMERGENCY AS A RESULT OF A TRANSFER BY THE EMERGENCY MEDICAL TEAM. AFTER AN X-RAY EXAMINATION, THE PATIENT WAS FOUND TO HAVE AN ABG STEM FRACTURE OF THE RIGHT HIP. THE ABG STEM IN 2008. ON (B)(6) 2022 REVISION SURGERY OF THE RIGHT HIP JOINT WAS PERFORMED (REMOVAL OF THE ABG ENDOPROSTHESIS STEM REMOVAL OF THE CAP HEAD. OPEN SETTING OF THE FRACTURE WITH INTERNAL STABILIZATION (FEMUR)). REPLACEMENT OF THE STEM AND FEMORAL HEAD WAS PERFORMED. THERE IS A DRILLING ON THE STEM, (A HOLE) WHICH WAS MADE TO REMOVE THE STEM DURING THE SURGERY.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s)

  MAUDE report 15885896 ↗
• InjurySep 30, 2021Degraded; Fracture; Degraded; Fracture

  THE PATIENT REPORTED TO THE HOSPITAL AND WAS ADMITTED TO THE ORTHOPEDICS DEPARTMENT DUE TO PAIN AND LIMB SHORTENING. THE PERFORMED DIAGNOSTICS REVEALED INCORRECT POSITIONING OF THE HIP JOINT PROSTHESIS COMPONENTS, IN PARTICULAR THE STEM AND HEAD (SUSPECTED STEM FRACTURE). DURING THE REVISION OF THE HIP ARTHROPLASTY, A PARTIAL FRACTURE OF THE STEM CONE AND SIGNIFICANT ABRASION ON THE SURFACES OF THE STEM CONE, HEAD AND POLYETHYLENE INSERT WAS REPORTED. DURING THE REVISION PROCEDURE, THE PATIENT WAS FITTED WITH THE STRYKER SYSTEM: RESTORATION MODULAR STEM, CERAMIC HEAD, POLYETHYLENE INSERT. DUE TO THE CORRECT SEATING, THE ACETABULAR ELEMENT WAS LEFT IN THE OPERATOR'S DECISION.

  Patient problems: Ambulation or Postural Difficulties; Pain; Unequal Limb Length

  MAUDE report 12553241 ↗