Alteon 01-010-22-4245Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
All models of Alteon (135)
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 10885862282163), received between Apr 24, 2024 and Apr 24, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
Patient problems
- Bone Fracture(s)1
- Periprosthetic fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 24, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
AS REPORTED, THE PATIENT HAD AN ORIGINAL COMPETITORS TOTAL HIP REPLACEMENT. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2024 FOR METAL-ON-METAL IMPLANT REVISION TO POLY AND POSSIBLE LOOSE IMPLANTS. IN THE FIRST REVISION SURGERY ON (B)(6) 2024 THE ORIGINAL COMPETITORS FEMORAL STEM PRESENTED TO BE LOOSE AND UNSTABLE. THE IMPLANT WAS REMOVED AND REPLACED WITH AN EXACTECH 22MMX245MM MONOBLOC HIP STEM AND 40MM +0MM HEAD AND A COMPETITORS POLY LINER IN THE ORIGINAL CUP. IT WAS NOTED IN THE REVISION SURGERY THAT THE PATIENT HAD THIN PROXIMAL FEMORAL CORTICES. POSTOPERATIVELY THE PATIENT PRESENTED BACK TO THE SURGEON'S OFFICE WITH A HAIRLINE FEMUR FRACTURE TO WHICH THE PATIENT WAS MADE NON-WEIGHT BEARING. THE PATIENT PRESENTED BACK WITH A DISPLACED FEMORAL HIP FRACTURE THAT REQUIRED REVISION SURGERY TO ORIF. THE SECOND REVISION HIP SURGERY FOR FEMORAL FRACTURE WAS SCHEDULED FOR (B)(6) 2024. THE PATIENT WAS REVISED TO A 22MMX295MM MONOBLOC HIP STEM AND 40MM +0MM HEAD ALONG WITH A LATER FEMORAL HIP DIFFERENT COMPETITORS FRACTURE PLATE, SCREW, AND CABLES. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Bone Fracture(s); Periprosthetic fracture
MAUDE report 19177729 ↗
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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