Patient Matched ImplantsRecalls & reported problems across all models
Biomet Orthopedics, LLC · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls
- 0
We found 9 models of Patient Matched Implants by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Mar 21, 2023 and Jan 9, 2026 — classified as 29 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (23 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 Patient Matched Implants problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth23
- Adverse Event Without Identified Device or Use Problem12
- Migration6
- Fracture1
Patient problems
- Aseptic loosening16
- Bone Fracture(s)12
- Pain12
- Osteopenia/ Osteoporosis11
- Failure of Implant7
- Unequal Limb Length7
- Joint Dislocation6
Patient Matched Implants models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Patient Matched Implants CP161944PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- Patient Matched Implants CP161942PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- Patient Matched Implants CP161943PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- Patient Matched Implants CP161941PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- Patient Matched Implants CP161949PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- Patient Matched Implants CP161945PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- Patient Matched Implants CP161951PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- Patient Matched Implants CP161947PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- Patient Matched Implants CP161940PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
Recent Patient Matched Implants adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 9, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY ONE (1) YEAR POST-IMPLANTATION, THE PATIENT EXPERIENCED BONE LOSS WITH IMPLANT MIGRATION AND LOOSENING. SUBSEQUENTLY, A REVISION PROCEDURE IS PENDING. IT WAS NOTED THAT THE PATIENT HAS A HIGHER BODY WEIGHT (REPORTED TO BE 300+). A NEW TRIFLANGE IMPLANT IS CURRENTLY IN PROCESS WITH THE MANUFACTURER, AND A REVISION DATE HAS NOT YET BEEN SCHEDULED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Aseptic loosening; Osteopenia/ Osteoporosis
MAUDE report 24020861 ↗InjuryJan 9, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY ONE (1) YEAR POST-IMPLANTATION, THE PATIENT EXPERIENCED BONE LOSS WITH IMPLANT MIGRATION AND LOOSENING. SUBSEQUENTLY, A REVISION PROCEDURE IS PENDING. IT WAS NOTED THAT THE PATIENT HAS A HIGHER BODY WEIGHT (REPORTED TO BE 300+). A NEW TRIFLANGE IMPLANT IS CURRENTLY IN PROCESS WITH THE MANUFACTURER, AND A REVISION DATE HAS NOT YET BEEN SCHEDULED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Aseptic loosening; Osteopenia/ Osteoporosis
MAUDE report 24020752 ↗InjuryJan 9, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY ONE (1) YEAR POST-IMPLANTATION, THE PATIENT EXPERIENCED BONE LOSS WITH IMPLANT MIGRATION AND LOOSENING. SUBSEQUENTLY, A REVISION PROCEDURE IS PENDING. IT WAS NOTED THAT THE PATIENT HAS A HIGHER BODY WEIGHT (REPORTED TO BE 300+). A NEW TRIFLANGE IMPLANT IS CURRENTLY IN PROCESS WITH THE MANUFACTURER, AND A REVISION DATE HAS NOT YET BEEN SCHEDULED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Aseptic loosening; Osteopenia/ Osteoporosis
MAUDE report 24020711 ↗InjuryJan 9, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY ONE (1) YEAR POST-IMPLANTATION, THE PATIENT EXPERIENCED BONE LOSS WITH IMPLANT MIGRATION AND LOOSENING. SUBSEQUENTLY, A REVISION PROCEDURE IS PENDING. IT WAS NOTED THAT THE PATIENT HAS A HIGHER BODY WEIGHT (REPORTED TO BE 300+). A NEW TRIFLANGE IMPLANT IS CURRENTLY IN PROCESS WITH THE MANUFACTURER, AND A REVISION DATE HAS NOT YET BEEN SCHEDULED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Aseptic loosening; Osteopenia/ Osteoporosis
MAUDE report 24020689 ↗InjuryNov 12, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT HIP REVISION. THE PATIENT FELL AND DISASSOCIATED THE IMPLANT FROM THE PELVIS. THE TRIFLANGE SCREWS HAD STARTED TO RIP OUT FROM THE PELVIS FOLLOWING THE FALL. NO KNOWN REVISION HAS TAKEN PLACE.ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 23534843 ↗InjuryNov 12, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT HIP REVISION. THE PATIENT FELL AND DISASSOCIATED THE IMPLANT FROM THE PELVIS. THE TRIFLANGE SCREWS HAD STARTED TO RIP OUT FROM THE PELVIS FOLLOWING THE FALL. NO KNOWN REVISION HAS TAKEN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 23534826 ↗InjuryNov 12, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT HIP REVISION. THE PATIENT FELL AND DISASSOCIATED THE IMPLANT FROM THE PELVIS. THE TRIFLANGE SCREWS HAD STARTED TO RIP OUT FROM THE PELVIS FOLLOWING THE FALL. NO KNOWN REVISION HAS TAKEN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 23534491 ↗InjuryNov 12, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT HIP REVISION. THE PATIENT FELL AND DISASSOCIATED THE IMPLANT FROM THE PELVIS. THE TRIFLANGE SCREWS HAD STARTED TO RIP OUT FROM THE PELVIS FOLLOWING THE FALL. NO KNOWN REVISION HAS TAKEN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 23534359 ↗InjuryNov 12, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT HIP REVISION. THE PATIENT FELL AND DISASSOCIATED THE IMPLANT FROM THE PELVIS. THE TRIFLANGE SCREWS HAD STARTED TO RIP OUT FROM THE PELVIS FOLLOWING THE FALL. NO KNOWN REVISION HAS TAKEN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 23534336 ↗InjuryNov 12, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT HIP REVISION. THE PATIENT FELL AND DISASSOCIATED THE IMPLANT FROM THE PELVIS. THE TRIFLANGE SCREWS HAD STARTED TO RIP OUT FROM THE PELVIS FOLLOWING THE FALL. NO KNOWN REVISION HAS TAKEN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 23534266 ↗InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT IS BEING CONSIDERED FOR A LEFT HIP REVISION DUE TO LOOSENING OF THE ACETABULAR TRIFLANGE COMPONENT AND ACETABULAR BONE FRACTURE DUE TO UNKNOWN REASON. PATIENT IS EXPERIENCING PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Bone Fracture(s); Pain
MAUDE report 22803236 ↗InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT IS BEING CONSIDERED FOR A LEFT HIP REVISION DUE TO LOOSENING OF THE ACETABULAR TRIFLANGE COMPONENT AND ACETABULAR BONE FRACTURE DUE TO UNKNOWN REASON. PATIENT IS EXPERIENCING PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Bone Fracture(s); Pain
MAUDE report 22803232 ↗InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT IS BEING CONSIDERED FOR A LEFT HIP REVISION DUE TO LOOSENING OF THE ACETABULAR TRIFLANGE COMPONENT AND ACETABULAR BONE FRACTURE DUE TO UNKNOWN REASON. PATIENT IS EXPERIENCING PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Bone Fracture(s); Pain
MAUDE report 22803228 ↗InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT IS BEING CONSIDERED FOR A LEFT HIP REVISION DUE TO LOOSENING OF THE ACETABULAR TRIFLANGE COMPONENT AND ACETABULAR BONE FRACTURE DUE TO UNKNOWN REASON. PATIENT IS EXPERIENCING PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Bone Fracture(s); Pain
MAUDE report 22803227 ↗InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT IS BEING CONSIDERED FOR A LEFT HIP REVISION DUE TO LOOSENING OF THE ACETABULAR TRIFLANGE COMPONENT AND ACETABULAR BONE FRACTURE DUE TO UNKNOWN REASON. PATIENT IS EXPERIENCING PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Bone Fracture(s); Pain
MAUDE report 22803226 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 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.
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