Alteon 188-01-06Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

All models of Alteon (135)

Data updated Oct 16, 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 10885862250957), received between Aug 6, 2024 and Aug 6, 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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Loosening of Implant Not Related to Bone-Ingrowth1
Unstable1

Patient problems

Joint Laxity1
Osteolysis1
Pain1
Synovitis1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryAug 6, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth
LEGAL CASE ¿ USA. PATIENT ID: MARGARET SIMPSON + LEFT HIP. 8/5/24: ADDITIONAL INFORMATION IN IN-BOX ON 8/1/24: ATTACHED EMAIL, EBI REPORT, INITIAL OP REPORT/IMPLANT LOG, AND REVISION OP REPORT. ADDED LINER DEVICE INFORMATION TO (B)(4). ADDED STEM DEVICE INFORMATION TO PRODUCT INFORMATION. IT WAS REPORTED THAT APPROXIMATELY 84 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS ACCELERATED POLYETHYLENE WEAR; UNSTABLE HIP WITH EARLY ANTERIOR IMPINGEMENT; MODEST BONE LOSS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED FAILED LEFT TOTAL HIP REPLACEMENT DUE TO ACCELERATED POLYETHYLENE WEAR. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PROCEDURE: REVISION LEFT TOTAL HIP REPLACEMENT OF ACETABULAR LINER AND FEMORAL STEM AND HEAD WITH DEBRIDEMENT OF ILIOPSOAS BURSITIS AND EXTENSIVE CIRCUMFERENTIAL DEBRIDEMENT OF INFLAMED PSEUDO-CAPSULAR TISSUE. JUST DEP TO THE CAPSULE LAYER WAS A PSEUDOCAPSULE, WHICH WAS YELLOWISH AND INFLAMED, EXHIBITING THICKENING AND FRONDS OF SYNOVITIS. THIS WAS CIRCUMFERENTIALLY EXCISED, TAKING CARE TO REMOVE ALL THE TIS
Patient problems: Joint Laxity; Osteolysis; Pain; Synovitis
MAUDE report 19916696 ↗

Device details

UDI-DI	`10885862250957`
Brand	Alteon
Model	188-01-06
Company	Exactech, Inc.
Product code	MEH · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
Class	Class 2
FDA submission	K140674
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	Jul 6, 2018

Device type (GMDN): Press-fit femoral stem prosthesis

A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].

Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate devices

Novation 130-32-51
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CORAIL 3L92511
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Acumatch A Series 138-36-29
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Novation 136-32-51
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
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Novation 130-32-53
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls33 reports
Novation 132-32-51
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls26 reports
Novation 136-36-53
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls22 reports

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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