TMJ SYSTEMRecalls & reported problems across all models
Biomet Microfixation, Inc · 36 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 458
- Deaths reported
- 0
- Injuries reported
- 449
- Recalls
- 0
We found 36 models of TMJ SYSTEM by Biomet Microfixation, Inc in the FDA's device registry (GUDID). Together they are named in 458 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2016 and Sep 2, 2026 — classified as 449 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (35 reports).
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
Most reported TMJ SYSTEM problems
Device problems
- Adverse Event Without Identified Device or Use Problem316
- Device Dislodged or Dislocated35
- Patient Device Interaction Problem25
- Insufficient Device Problem Information24
- Patient-Device Incompatibility22
- Noise, Audible20
- Malposition of Device19
- Migration15
Patient problems
- Pain220
- Loss of Range of Motion74
- No Information65
- Insufficient Information49
- Difficulty Chewing48
- Extraskeletal ossification48
- No Clinical Signs, Symptoms or Conditions42
- Unspecified Infection38
TMJ SYSTEM models
36 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TMJ SYSTEM 24-6563Joint, Temporomandibular, Implant89 reports
- TMJ SYSTEM 24-6562Joint, Temporomandibular, Implant76 reports
- TMJ SYSTEM 99-6577Plate, Bone37 reports
- TMJ SYSTEM 24-6545Joint, Temporomandibular, Implant24 reports
- TMJ SYSTEM 24-6551Joint, Temporomandibular, Implant24 reports
- TMJ SYSTEM 01-6546Joint, Temporomandibular, Implant19 reports
- TMJ SYSTEM 99-6579Plate, Bone19 reports
- TMJ SYSTEM 24-6546Joint, Temporomandibular, Implant18 reports
- TMJ SYSTEM 01-6545Joint, Temporomandibular, Implant15 reports
- TMJ SYSTEM 24-6556Joint, Temporomandibular, Implant14 reports
- TMJ SYSTEM 24-6561Joint, Temporomandibular, Implant13 reports
- TMJ SYSTEM 24-6550Joint, Temporomandibular, Implant13 reports
- TMJ SYSTEM 24-6560Joint, Temporomandibular, Implant12 reports
- TMJ SYSTEM 24-6555Joint, Temporomandibular, Implant10 reports
- TMJ SYSTEM 01-6550Joint, Temporomandibular, Implant8 reports
- TMJ SYSTEM 99-6581Plate, Bone6 reports
- TMJ SYSTEM 01-6551Joint, Temporomandibular, Implant6 reports
- TMJ SYSTEM 99-6587Plate, Bone5 reports
- TMJ SYSTEM 24-6651Joint, Temporomandibular, Implant5 reports
- TMJ SYSTEM 24-6645Joint, Temporomandibular, Implant5 reports
- TMJ SYSTEM 24-6546TIJoint, Temporomandibular, Implant5 reports
- TMJ SYSTEM 99-6589Plate, Bone4 reports
- TMJ SYSTEM 24-6545TIJoint, Temporomandibular, Implant4 reports
- TMJ SYSTEM 01-6545TIJoint, Temporomandibular, Implant4 reports
- TMJ SYSTEM 01-6546TIJoint, Temporomandibular, Implant4 reports
- TMJ SYSTEM 24-6646Joint, Temporomandibular, Implant3 reports
- TMJ SYSTEM 24-6550TIJoint, Temporomandibular, Implant3 reports
- TMJ SYSTEM 24-6555TIJoint, Temporomandibular, Implant2 reports
- TMJ SYSTEM 24-6551TIJoint, Temporomandibular, Implant2 reports
- TMJ SYSTEM 24-6556TIJoint, Temporomandibular, Implant2 reports
- TMJ SYSTEM 01-6550TIJoint, Temporomandibular, Implant2 reports
- TMJ SYSTEM 24-6564Joint, Temporomandibular, Implant1 report
- TMJ SYSTEM 24-6565Joint, Temporomandibular, Implant1 report
- TMJ SYSTEM 24-6614Drills, Burrs, Trephines & Accessories (Simple, Powered)1 report
- TMJ SYSTEM 24-6650Joint, Temporomandibular, Implant1 report
- TMJ SYSTEM 01-6551TIJoint, Temporomandibular, Implant1 report
Recent TMJ SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Insufficient Information
MAUDE report 50566974 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Insufficient Information
MAUDE report 50566971 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Insufficient Information
MAUDE report 50565923 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
It was reported the patient underwent a TMJ procedure and was subsequently revised approximately 2 years and 8 months post-implantation for an unknown reason. Attempts have been made and no further information has been provided.
Patient problems: Insufficient Information
MAUDE report 50565917 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
It was reported that the patient underwent bilateral temporomandibular joint replacements. Subsequently, the patient underwent a right revision procedure approximately seven (7) years post-implantation. The mandible and fossa were removed and replaced due to unknown reasons. Attempts have been made and no further information has been provided.
Patient problems: Insufficient Information; Swelling/ Edema
MAUDE report 50279198 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
It was reported that the patient underwent bilateral temporomandibular joint replacements. Subsequently, the patient underwent a right revision procedure approximately seven (7) years post-implantation. The mandible and fossa were removed and replaced due to unknown reasons. Attempts have been made and no further information has been provided.
Patient problems: Insufficient Information; Swelling/ Edema
MAUDE report 50279195 ↗InjuryJul 27, 2026Malposition of Device
It was reported that approximately 2 years post-implantation the patient alleges the right implant was extending into the ear and causing hearing loss. Further, the patient described a sensation like cotton in the right ear with some discomfort but no pain. The patient is speaking with the surgeon, but no further intervention has been reported to date.Attempts have been made and no further information has been provided.
Patient problems: Discomfort; Partial Hearing Loss
MAUDE report 50036260 ↗InjuryJul 27, 2026Malposition of Device
It was reported that approximately 2 years post-implantation the patient alleges the right implant was extending into the ear and causing hearing loss. Further, the patient described a sensation like cotton in the right ear with some discomfort but no pain. The patient is speaking with the surgeon, but no further intervention has been reported to date.Attempts have been made and no further information has been provided.
Patient problems: Discomfort; Partial Hearing Loss
MAUDE report 50036259 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL BILATERAL TEMPOROMANDIBULAR JOINT PROCEDURE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN AND TIGHTNESS APPROXIMATELY EIGHT YEARS POST-IMPLANTATION. IT IS FURTHER ALLEGED BY THE PATIENT THAT THE SCREWS ARE COMING LOOSE AND PUSHING OUT. THE PATIENT IS TRYING TO FIND A SURGEON TO HAVE THE IMPLANTS REMOVED BUT HAS NOT FOUND ONE THAT WILL DO THE SURGERY. THERE HAS BEEN NO INTERVENTION TO DATE.
Patient problems: Pain
MAUDE report 25451137 ↗MalfunctionFeb 2, 2026Migration
IT WAS REPORTED THAT A PATIENT WITH TEMPOROMANDIBULAR JOINT PROSTHESES EXPERIENCED RIGHT-SIDED IMPLANT SHIFTING WITH IMPINGEMENT TOWARD THE EAR CANAL. NO FURTHER INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24234339 ↗MalfunctionFeb 2, 2026Migration
IT WAS REPORTED THAT A PATIENT WITH TEMPOROMANDIBULAR JOINT PROSTHESES EXPERIENCED RIGHT-SIDED IMPLANT SHIFTING WITH IMPINGEMENT TOWARD THE EAR CANAL. NO FURTHER INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24234267 ↗InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN AFTER UNDERGOING A LEFT TMJ PROCEDURE APPROXIMATELY 8 YEARS AGO. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 23513180 ↗InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN AFTER UNDERGOING A LEFT TMJ PROCEDURE APPROXIMATELY 8 YEARS AGO. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 23513152 ↗InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Extraskeletal ossification; Loss of Range of Motion; Pain
MAUDE report 23335332 ↗InjurySep 8, 2025Fracture; Fracture
IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT TMJ PROCEDURE. THE PATIENT EXPERIENCED RIGHT FACIAL PAIN AND UNDERWENT A REVISION PROCEDURE APPROXIMATELY (4) YEARS POST-IMPLANTATION DUE TO IMPLANT FRACTURE. ALL FRAGMENTS OF THE MANDIBLE IMPLANT WERE REMOVED AND THE FOSSA COMPONENT WAS RETAINED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 22992029 ↗
Other Biomet Microfixation, Inc products
- "1.5MM" SYSTEM35 models · 224 reports
- STERNALOCK BLU SYSTEM31 models · 122 reports
- 2.0 LACTOSORB SYSTEM16 models · 110 reports
- TRAUMAONE SYSTEM39 models · 80 reports
- 2.4MM SYSTEM7 models · 70 reports
- RIBFIX BLU SYSTEM19 models · 56 reports
- PECTUS SYSTEM35 models · 55 reports
- STERNALOCK 360 SYSTEM3 models · 51 reports
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.
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