AlteonRecalls & reported problems across all models
Exactech, Inc. · 135 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Alteon model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 100
- Deaths reported
- 0
- Injuries reported
- 94
- Recalls
- 3
We found 135 models of Alteon by Exactech, Inc. in the FDA's device registry (GUDID). Together they are named in 100 adverse event reports in the FDA's MAUDE database, received between Sep 16, 2019 and Sep 14, 2026 — classified as 94 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (47 reports).
3 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Alteon recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 31, 2024Open, Classified
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Z-1167-2025 · Root cause: Nonconforming Material/Component · names 82 of these models · Recall details · FDA record ↗
- Nov 21, 2023Open, Classified
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Z-0578-2024 · Root cause: Packaging change control · names 3 of these models · Recall details · FDA record ↗
- Nov 7, 2016Terminated
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Z-1032-2017 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Alteon problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth47
- Adverse Event Without Identified Device or Use Problem30
- Migration12
- Naturally Worn4
- Positioning Failure3
- Positioning Problem3
- Unstable3
- Break2
Patient problems
- Failure of Implant37
- Pain26
- Bone Fracture(s)14
- Osteolysis14
- Insufficient Information13
- Joint Laxity8
- Synovitis8
- Aseptic loosening6
Alteon models
135 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Alteon 01-030-42-0536Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls2 reports
- Alteon 01-030-40-0636Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls1 report
- Alteon 01-030-40-0640Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls0 reports
- Alteon 01-030-42-0740Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall2 reports
- Alteon 01-030-40-0332Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall1 report
- Alteon 01-030-40-0436Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall1 report
- Alteon 01-030-40-0736Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall1 report
- Alteon 01-030-42-0436Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall1 report
- Alteon 01-030-42-0640Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall1 report
- Alteon 162-00-06Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall0 reports
- Alteon 01-030-40-0022Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0122Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0128Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0222Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0228Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0232Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0322Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0328Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0422Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0428Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0432Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0522Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0528Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0532Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0536Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0622Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0628Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0632Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0722Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0728Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0732Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0740Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0822Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0828Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0832Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0836Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-40-0840Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0128Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0228Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0232Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0328Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0332Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0428Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0432Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0528Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0532Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0628Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0632Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0636Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0728Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0732Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0736Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0828Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0832Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0836Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-42-0840Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Alteon 01-030-46-0022Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-46-0128Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-46-0232Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-46-0332Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-46-0432Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-46-0436Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-46-0532Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-46-0536Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-46-0632Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-46-0636Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-46-0640Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-46-0736Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-46-0740Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-46-0836Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-46-0840Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-48-0128Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-48-0232Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-48-0332Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-48-0532Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-48-0536Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-48-0632Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-48-0636Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-48-0640Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-48-0736Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-48-0740Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-48-0836Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 01-030-48-0840Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Alteon 180-65-25Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented6 reports
- Alteon 180-65-20Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented5 reports
- Alteon 190-31-08Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate5 reports
- Alteon 190-30-05Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate4 reports
- Alteon 190-30-08Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate4 reports
- Alteon 190-31-07Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 reports
- Alteon 190-30-06Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 reports
- Alteon 188-00-05Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 reports
- Alteon 188-01-02Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 reports
- Alteon 180-65-30Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- Alteon 01-010-21-4245Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Alteon 190-31-03Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 reports
- Alteon 190-31-04Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 reports
- Alteon 190-31-06Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 reports
- Alteon 190-30-03Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 reports
- Alteon 190-30-04Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 reports
- Alteon 190-30-07Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 reports
Recent Alteon adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Loss of Osseointegration
Report #2 of 2 for this eventIt was reported this patient underwent an initial right total hip arthroplasty. Subsequently, four and half (4.5) years later, the patient experienced worsening pain in right hip. As a result, the patient underwent a right knee revision procedure. The patient was revised to another manufacturer's construct. A revision operative report was provided. Intraoperatively, a loose femoral stem with no bony ingrowth was observed. The residual acetabulum was then inspected and found to be intact. The condition of the acetabular liner was not mentioned in the operative report. The patient was transferred to a bed and brought to the recovery room in stable condition. The patient tolerated the procedure well. There were no intra-operative complications. No further information is available.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 50752471 ↗InjurySep 1, 2026Positioning Problem
Patient problems: Insufficient Information
MAUDE report 50551492 ↗InjuryApr 21, 2026Unstable; Device Dislodged or Dislocated
AS REPORTED, APPROXIMATELY 3 YEARS AND 1 MONTH POST THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY, AND FOLLOWING MULTIPLE DISLOCATIONS AND PAIN, THE PATIENT WAS REVISED DUE TO INSTABILITY AND THE RECALLED LINER WAS REMOVED. STABILITY OF THE ACETABULAR COMPONENT WAS CHECKED AND FOUND TO BE ADEQUATE AND STABLE. A HIP ASPIRATION DEMONSTRATED NO GROWTH ON CULTURE AND WAS NOT INDICATIVE OF INFECTION. THE PATIENT WAS DISCHARGED HOME WITH HOME HEALTH.
Patient problems: Joint Dislocation; Joint Laxity; Pain
MAUDE report 24948330 ↗InjuryMar 30, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL HIP REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, DISCOMFORT, OSTEOLYSIS AND ASEPTIC LOOSENING SECONDARY TO PROSTHESIS WEAR. AS A RESULT, APPROXIMATELY FOUR YEARS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. IT WAS NOTED THE PATIENT HAD DENSE SCAR TISSUE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 FOR THIS EVENT/PATIENT.
Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Osteolysis; Pain; Scar Tissue
MAUDE report 24732664 ↗InjuryMar 30, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL HIP REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, DISCOMFORT, OSTEOLYSIS AND ASEPTIC LOOSENING SECONDARY TO PROSTHESIS WEAR. AS A RESULT, APPROXIMATELY FOUR YEARS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. IT WAS NOTED THE PATIENT HAD DENSE SCAR TISSUE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3 FOR THIS EVENT/PATIENT.
Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Osteolysis; Pain; Scar Tissue
MAUDE report 24730834 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
THIS PATIENT PREVIOUSLY UNDERWENT A TOTAL HIP ARTHROPLASTY (THA) ON THE LEFT SIDE. FOLLOWING THIS PROCEDURE, THE PATIENT SUSTAINED A FEMORAL FRACTURE. THE PATIENT WAS SCHEDULED FOR FEMORAL FRACTURE FIXATION AND AN ACETABULAR LINER EXCHANGE. THE FEMORAL FRACTURE WAS CONSIDERED STABILIZED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Bone Fracture(s)
MAUDE report 24524526 ↗InjuryFeb 20, 2026Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED, THE PATIENT HAD AN INITIAL THA. THE PATIENT WAS REVISED ON DUE TO POLY WEAR AND OSTEOLYSIS IN THE ACETABULUM AND PROXIMAL FEMUR. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.
Patient problems: Aseptic loosening; Osteolysis; Pain; Synovitis
MAUDE report 24401544 ↗InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT CONVERSION FROM AN IMFEMORAL NAIL TO A LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, DURING PHYSICAL THERAPY AND WEIGHT-BEARING, THE PATIENT EXPERIENCED A MIDSHAFT FEMORAL FRACTURE. AS A RESULT, THE PATIENT UNDERWENT AN ATTEMPTED SURGERY THE DAY AFTER INITIAL IMPLANTATION WHICH HAD TO BE ABORTED DUE TO BLOOD LOSS. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE. THE REVISION WAS COMPLETED AT A LATER DATE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24035353 ↗InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT CONVERSION FROM AN IM FEMORAL NAIL TO A LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, DURING PHYSICAL THERAPY AND WEIGHT-BEARING, THE PATIENT EXPERIENCED A MIDSHAFT FEMORAL FRACTURE. AS A RESULT, THE PATIENT UNDERWENT A REVISION SURGERY AND FRACTURE FIXATION APPROXIMATELY 3 WEEKS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Periprosthetic fracture
MAUDE report 23929463 ↗InjurySep 2, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THIS FEMALE PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 2 YEARS 3 MONTHS POST OP. THE PATIENT HAD AN ORIGINAL EXACTECH THA. THE PATIENT PRESENTED TO DOCTORS OFFICE WITH COMPLAINTS OF THEIR LEFT HIP. THE PATIENT REPORTED PAIN, INSTABILITY, AND DISSATISFACTION. IT WAS NOTED AND SHOWN ON THE X-RAY THAT THE ACETABULAR CUP IS NOT IN AN IDEAL POSITION. THE PATIENT WAS SCHEDULED FOR LEFT HIP REVISION WITH ACETABULAR CUP REVISION. THE PATIENT UNDERWENT LEFT HIP REVISION. DURING THE REVISION, THE FEMORAL HEAD WAS REMOVED. THE ACETABULAR CUP AND LINER WERE REMOVED, THE HIP JOINT WAS DEBRIDED, AND PREPPED FOR A NEW ZB G7 CLUSTER-HOLE CUP. IT WAS IMPLANTED WITH SCREWS AND A LIPPED LINER. A NEW 36MM +10 MM HEAD WAS IMPLANTED ON THE FEMORAL STEM. REPORTED EVENT IS NOT RELATED TO BREAKAGE OF A DEVICE AND DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: DISCARDED AT THE FACILITY
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain
MAUDE report 22938642 ↗InjuryAug 5, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED A 54 YO FEMALE PATIENT, WHO HAD A LEFT HIP IMPLANTED, UNDERWENT A REVISION PROCEDURE. THE PATIENT WAS REVISED DUE TO THE STEM WAS LOOSE AND NEEDED TO BE REVISED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN DUE TO HOSPITAL POLICY. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22723522 ↗InjuryJul 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A 68 YO MALE PATIENT, WHO HAD AN INITIAL LEFT HIP IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE OR WITH A LOOSE FEMORAL STEM. DURING THE REVISION, WHEN THE SURGEON ATTEMPTED TO HIT THE 32 MM FEMORAL HEAD OFF OF THE TRUNNION, THE STEM CAME OUT. THE PATIENT WAS REVISED TO A MONOBLOC STEM. THERE WERE NO DEVICE BREAKAGES DURING THE PROCEDURE. THERE WAS A SURGICAL DELAY, "REVISION SURGERY REQUIRED" INDICATED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY IMAGE WAS PROVIDED. THE EXPLANTED DEVICE WAS NOT AVAILABLE FOR RETURN AS THE HOSPITAL WILL NOT ALLOW. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22639721 ↗InjuryJul 23, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL HIP REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN SECONDARY TO FEMORAL LOOSENING. AS A RESULT, APPROXIMATELY FOUR YEARS AND ONE-MONTH POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 22575837 ↗InjuryJul 22, 2025Positioning Problem; Positioning Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT THA APPROXIMATELY 5 YEARS AGO. IT WAS NOTED BY THE SURGEON THAT "FINAL STEM REMAINED 2 MM UP FROM INTENDED". NO FURTHER INTERVENTION OR PATIENT IMPACT WAS REPORTED AS A RESULT OF THIS MALFUNCTION. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22570588 ↗InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT THA APPROXIMATELY 4 YEARS AGO. DURING INITIAL SURGERY THE SURGEON NOTED "MEDIAL CALCAR CRACK DURING STEM INSERTION. CONSIDERED CABLE". NO INTERVENTION OR FURTHER PATIENT IMPACT WAS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Bone Fracture(s)
MAUDE report 22570558 ↗
Other Exactech, Inc. products
- Equinoxe305 models · 2,076 reports · 37 recalls
- Optetrak Logic408 models · 3,306 reports · 3 recalls
- Novation184 models · 1,145 reports · 25 recalls
- Optetrak336 models · 1,773 reports · 6 recalls
- Truliant414 models · 1,010 reports · 2 recalls
- Acumatch A Series94 models · 54 reports · 15 recalls
- MCS25 models · 7 reports · 5 recalls
- Vantage66 models · 110 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page