ABG 4845-0107Recalls & reported problems
Howmedica Osteonics Corp. · Femoral Stem - Right · Class 2 · Implant
All models of ABG (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327050974), received between Oct 23, 2020 and Feb 10, 2026 — classified as 3 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Fracture2
Patient problems
- Ambulation or Postural Difficulties2
- Insufficient Information2
- High metal ion levels1
- Metal Related Pathology1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT REPORTED THAT HE ALLEGEDLY UNDERWENT RIGHT HIP REPLACEMENT SURGERY ON (B)(6) 2011, AND IN (B)(6) 2025 HE BEGAN EXPERIENCING CLICKING SOUNDS IN HIS RIGHT HIP. BLOOD TESTS WERE ORDERED AND RESULTS ALLEGEDLY SHOWED COBALT AT 17.5 AND CHROMIUM AT 6.1. ALLEGEDLY DURING THE REVISION SURGERY ON (B)(6) 2025, THE BALL COMPONENT WAS REPLACED WITH CLEANSING THE JOINT OF COBALT DEBRIS.
Patient problems: High metal ion levels; Metal Related Pathology
MAUDE report 24303035 ↗InjuryMar 28, 2024Fracture; Fracture
THE FOLLOWING WAS REPORTED: BROKEN ABG II STEM. ABG STEM WAS BROKEN WHEN IMPLANT WAS IN SITU, BECAUSE THE STEM WAS BROKEN THE PATIENT NEEDS TO BE REVISED.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 19001230 ↗InjuryOct 23, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
FRACTURE OF THE FEMORAL HEAD. THE FRACTURE OCCURRED WHEN THE PATIENT TURNED WHILE STANDING. DEVICE WAS IMPLANTED IN 2001.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 10725776 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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