ABG 4845-0207Recalls & reported problems

Howmedica Osteonics Corp. · Femoral Stem - Left · Class 2 · Implant

All models of ABG (10)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 4
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327051063), received between Jan 30, 2020 and Jan 6, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Detachment of Device or Device Component2
Corroded1
Fracture1
Insufficient Device Problem Information1

Patient problems

Ambulation or Postural Difficulties1
Fall1
Injury1
Insufficient Information1
Joint Dislocation1
Metal Related Pathology1
Necrosis1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

InjuryJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6) 2011 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ABGII CEMENTLESS HIP STEM. HIS LEFT HIP WAS REVISED ON (B)(6) 2023 ALLEGEDLY DUE TO HEAD DISASSOCIATION.
Patient problems: Insufficient Information
MAUDE report 21081839 ↗
InjuryFeb 26, 2023Corroded; Detachment of Device or Device Component; Corroded; Detachment of Device or Device Component
OUR AGENT REPORTED: "AN ABG STEM IMPLANT WITH MITCH, IMPLANTED OVER 11 YEARS AGO, HAS BEEN REVISED. THE LARGE HEAD CONSUMED THE MORSE TAPER OF THE STEM CAUSING DISLOCATION OF THE HEAD AND NECESSITATING THE REMOVAL OF THE STEM AND REIMPLANTATION OF A MODULAR RESTORATION WITH MDM".
Patient problems: Joint Dislocation; Metal Related Pathology; Necrosis
MAUDE report 16441456 ↗
InjuryAug 3, 2020Fracture; Fracture
THE CUSTOMER REPORTS A BROKEN HIP IMPLANT.
Patient problems: Ambulation or Postural Difficulties; No Known Impact Or Consequence To Patient
MAUDE report 10355358 ↗
InjuryJan 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT FELL AND FRACTURES AROUND STEM IMPLANT. ALL COMPONENTS WERE REMOVED INCLUDING CUP, AND REVISED TO A RESTORATION MODULAR STEM, TRIDENT PSL CUP AND MDM LINER. DALL MILES PLATE AND CABLES WERE ALSO APPLIED. NO MEDICAL REPORTS AVAILABLE. PRODUCT NOT AVAILABLE FOR RETURN.
Patient problems: Fall; Injury
MAUDE report 9646697 ↗

Device details

UDI-DI	`07613327051063`
Brand	ABG
Model	4845-0207
Company	Howmedica Osteonics Corp.
Product code	MEH · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Coated hip femur prosthesis, modular

A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

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All Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices →

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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