Comprehensive VRS GlenoidRecalls & reported problems across all models
Biomet Orthopedics, LLC · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls
- 0
We found 2 models of Comprehensive VRS Glenoid by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2019 and Mar 16, 2026 — classified as 34 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (13 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 Comprehensive VRS Glenoid problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth13
- Detachment of Device or Device Component7
- Device Dislodged or Dislocated6
- Adverse Event Without Identified Device or Use Problem5
- Fracture4
- Inadequacy of Device Shape and/or Size3
- Insufficient Device Problem Information3
- Malposition of Device3
Patient problems
- Failure of Implant12
- Insufficient Information8
- No Clinical Signs, Symptoms or Conditions7
- Pain7
- Joint Dislocation6
- Aseptic loosening3
- Joint Impingement3
- Bone Fracture(s)2
Comprehensive VRS Glenoid models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Comprehensive® VRS™ Glenoid 110027734shoulder prosthesis, reverse configuration37 reports
- Comprehensive® VRS Glenoid 110019066shoulder prosthesis, reverse configuration1 report
Recent Comprehensive VRS Glenoid adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS BEING CONSIDERED FOR A PRODUCT FOR AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Insufficient Information
MAUDE report 24604883 ↗MalfunctionJan 27, 2026Loss of Osseointegration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER PROCEDURE WITH IMPLANTATION OF A GLENOID COMPONENT. APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT PRESENTED WITH PAIN, AND RADIOGRAPHS SHOWED THAT ALL SCREWS SECURING THE GLENOID COMPONENT HAD FRACTURED. SUBSEQUENTLY, AN EXTRACTION SURGERY WAS PERFORMED APPROXIMATELY 25 MONTHS POST-IMPLANTATION. INTRA-OPERATIVELY, THE GLENOID COMPONENT WAS NOT INTEGRATED WITH BONE AND WAS FLOATING, ALLOWING FOR EASY MANUAL REMOVAL. ALL FRACTURED SCREWS WERE EXTRACTED USING A REMOVAL KIT. THE STEM REMAINED STABLE, AND THE STEM, TRAY, AND LINER WERE RETAINED. THE PATIENT HAD A HISTORY OF REOPERATION DUE TO INFECTION AND METAL ALLERGIES. THE PATIENT WAS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening
MAUDE report 24190631 ↗InjuryJan 2, 2026Difficult to Insert
IT WAS REPORTED THAT DURING A PROCEDURE, A NEW TAPER WAS ATTEMPTING TO BE IMPLANTED INTO THE EXISTING BASEPLATE AND WOULD NOT STAY ENGAGED. AS A RESULT, THE SURGEON DECIDED TO REMOVE THE BASEPLATE AND CONVERT THE PATIENT TO A HEMI-ARTHROPLASTY INSTEAD. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23946589 ↗InjuryDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; Pain
MAUDE report 23846292 ↗MalfunctionNov 26, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23656885 ↗InjuryOct 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TWO-STAGE REVISION DUE TO BONE EROSION TO RECEIVE ZB IMPLANTS FOR THE FIRST TIME APPROXIMATELY THIRTEEN (13) MONTHS AGO. SUBSEQUENTLY, THE PATIENT HAD BEEN REPORTED TO HAVE BEEN DOING WELL ACCORDING TO THE SURGEON BUT THEN REPORTED CRACKING AND PAIN AFTER A PHYSIOTHERAPY TREATMENT ON AN UNKNOWN DATE. SCANS SHOWED THE IMPLANT HAD BECOME LOOSE AND SCREW HAD SNAPPED. THE SURGEON CHOSE TO REMOVE THE IMPLANTS APPROXIMATELY FOUR (4) MONTHS AGO AND SHOWED THAT THE IMPLANT WAS MOST LIKELY LOOSE OR NOT ENOUGH FIXATION WAS PRESENT TO PREVENT THE ABOVE INCIDENT. AS A RESULT, A HEMI WAS PUT IN WHILE WAITING FOR A NEW CUSTOM DEVICE TO BE PUT IN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Pain
MAUDE report 23304671 ↗InjuryOct 15, 2025Positioning Failure; Inadequacy of Device Shape and/or Size; Positioning Failure; Inadequacy of Device Shape and/or Size
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23279345 ↗MalfunctionJul 29, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT WHEN THE SURGEON ATTEMPTED TO IMPLANT THE IMPLANT INTO THE PATIENT THERE WAS A GAP BETWEEN THE PATIENT'S BONE AND THE IMPLANT. THIS RESULTED IN POOR RETENTION OF THE SCREW. THE SURGEON DETERMINED THAT THERE WAS A RISK OF THE COMPONENT BECOMING LOOSE AFTER THE SURGERY, SO A DIFFERENT IMPLANT WAS USED TO COMPLETE THE SURGER. ATTEMPT WAS MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22642539 ↗InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT ENTERED CLINICAL STUDY UPON REVISION OF RIGHT RTSA WITH REPAIR OF COMMUTED HUMERAL FRACTURE. SUBSEQUENTLY, THE PATIENT EXPERIENCED ONGOING PAIN WITH NO IDENTIFIED IMPLANT ABNORMALITIES AND RECEIVED INJECTION APPROXIMATELY 4 YEARS POST-IMPLANTATION WITH RESOLUTION. REMAINS IMPLANTED AT STUDY COMPLETION.
Patient problems: Implant Pain; Pain
MAUDE report 22610545 ↗InjuryApr 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21933861 ↗InjuryFeb 10, 2025Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS CONSIDERED FOR A PMI PRODUCT AND REVISED DUE TO LOOSENING/INSTABILITY OF THE IMPLANT. DURING THE REVISION, IT WAS NOTED THAT THE CENTRAL SCREW WAS FRACTURED. ALL COMPONENTS WERE REMOVED AND REPLACED; HOWEVER, A PIECE OF THE FRACTURED CENTRAL SCREW COULD NOT BE REMOVED AS IT WAS RETAINED IN THE GLENOID.
Patient problems: Failure of Implant
MAUDE report 21351606 ↗InjuryDec 5, 2024Adverse 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 FURTHER REPORTED THAT A PATIENT IS BEING CONSIDERED FOR AN UPCOMING REVISION DUE TO VRS BASEPLATE LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 20852588 ↗InjuryDec 5, 2024Adverse 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 A PATIENT UNDERWENT AN INITIAL SHOULDER PROCEDURE APPROXIMATELY 15 MONTHS AGO. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO BASEPLATE LOOSENING AND SCREW FRACTURES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 20852573 ↗InjuryOct 2, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS FURTHER REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 13 MONTHS POST IMPLANTATION DUE TO GLENOID LOOSENING AND PAIN IN THE SHOULDER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Pain
MAUDE report 20351743 ↗InjuryOct 1, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 20346717 ↗
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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