Novation 186-03-54Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
All models of Novation (184)
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 10885862244369), received between Nov 1, 2024 and Nov 1, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Ambulation or Postural Difficulties1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Balance Problems1
- Discomfort1
- Osteolysis1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
LEGAL CASE ¿ USA (MDL NO. 3044) (NGG) (MMH) CASE NO: 1:23-CV-08008 10/30/24: ADDITIONAL INFORMATION RECEIVED. SUMMARIZED REVISION OP REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES: LEFT HIP REPLACEMENT LOOSENING AND OSTEOLYSIS. INDICATIONS: A 59-YEAR-OLD FEMALE WHO PREVIOUSLY HAD UNDERGONE TOTAL HIP REPLACEMENT WITH SUBSEQUENT POLYETHYLENE WEAR ASSOCIATED OSTEOLYSIS. SHE HAD PAIN AND RADIOGRAPHS, WERE CONSISTENT WITH SIGNIFICANT ACETABULAR OSTEOLYSIS. DESCRIPTION OF PROCEDURE: THE HIP WAS DISLOCATED. THE FEMORAL HEAD WAS REMOVED FROM THE TRUNNION. WE THEN DEBRIDED AROUND THE ACETABULAR COMPONENT AND CREATED A POCKET ANTERIORLY TO SUBLUX THE FEMUR TO THE FRONT. THE ACETABULAR LINER WAS THEN REMOVED FROM THE ACETABULAR SHELL. WE THEN REMOVED THE PREVIOUS COMPONENT SCREWS. THE ORIGINAL LINER WAS REPLACED AND THE CUP REMOVAL SYSTEM UTILIZED TO REMOVE THE CUP WITH ESSENTIALLY NO BONE LOSS. THE PATIENT WAS REVISED TO AN EXACTECH FEMORAL HEAD AND COMPETITOR¿S ACETABULAR DEVICES. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. THERE WERE NO IMMEDIATE COMPLICATIONS. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 201
Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Osteolysis; Pain
MAUDE report 20591503 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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