Omnifit 6098-0530Recalls & reported problems
Howmedica Osteonics Corp. · 132 Degree Cemented Hip Stem · Class 2 · Implant
All models of Omnifit (43)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327022469), received between Jan 16, 2019 and Jan 16, 2019 — classified as 1 injury.
2 other recalls cover devices cleared under the same FDA submission (K983226); 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bone Fracture(s)1
- Fall1
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD A CEMENTED TOTAL HIP REPLACEMENT APPROXIMATELY 14 YEARS AGO. PATIENT HAS DONE WELL UNTIL A RECENT FALL ON THE ICE. PATIENT SUSTAINED A PERIPROSTHETIC FRACTURE. SURGEON ALLEGES NO DEFECT OF THE IMPLANTS. FRACTURE WAS REPAIRED WITH CABLES. FEMORAL COMPONENT WAS REMOVED AND REPLACED.. THE LINER WAS REPLACED. OPERATION COMPLETED SUCCESSFULLY. UPDATE 28/DECEMBER/2018: PATIENT'S FEMUR WAS FRACTURED.
Patient problems: Bone Fracture(s); Fall; Injury
MAUDE report 8253443 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K983226. One submission often covers many models, so check the product and lot details in each record.
- Z-0898-2009 · Nov 13, 2008 · TerminatedOmnifit FC Cemented Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in prima
- Z-0899-2009 · Nov 13, 2008 · TerminatedOmnifit Eon These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revisio
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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