Comprehensive® VRS™ Glenoid 110027734Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Comprehensive VRS Glenoid (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet Comprehensive VRS reverse shoulder prosthesis is an implant used in total shoulder replacement. The 38 reports mostly describe the glenoid component loosening or coming free, screws breaking, parts detaching or dislocating, and resulting pain, with several patients needing revision surgery. There were 34 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00880304818934), received between Nov 15, 2019 and Mar 16, 2026 — classified as 33 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (13 reports).
1 other recall cover devices cleared under the same FDA submission (K152754, K202232); they may or may not involve this specific model.
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 18, 2026.
Reports received per month
Most reported 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
- Pain7
- Joint Dislocation6
- No Clinical Signs, Symptoms or Conditions6
- Aseptic loosening3
- Joint Impingement3
- Bone Fracture(s)2
Recent adverse event reports
The 25 most recent of 37 reports, 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 ↗InjuryMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Erosion; Osteopenia/ Osteoporosis; Pain
MAUDE report 19228197 ↗InjuryMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY TWO (2) MONTHS POST-IMPLANTATION DUE TO DISASSOCIATION OF THE TAPER ADAPTER FROM THE VRS COMPONENT. DURING THE REVISION, THE VRS COMPONENT REMAINED IMPLANTED WHILE THE TAPER ADAPTER WAS EXPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Erosion
MAUDE report 19228193 ↗InjuryApr 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY APPROXIMATELY 2 YEARS AGO AND IS BEING CONSIDERED FOR A REVISION DUE TO LOOSENING AND PAIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 19213312 ↗InjuryApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A FEW DAYS FOLLOWING AN INITIAL ARTHROSCOPY PROCEDURE, THE PATIENT EXPERIENCED IMPLANT DISSOCIATION. THE PATIENT UNDERWENT ADDITIONAL SURGERY APPROXIMATELY ONE (1) WEEK FOLLOWING THE ORIGINAL PROCEDURE, AND THE SURGEON DISCOVERED THAT THE CENTRAL SCREW WASN'T FULLY TIGHTENED, CAUSING THE LOOSENESS. THE SCREW WAS ADJUSTED, AND OTHER CONCOMITANT DEVICES WERE RETAINED DURING THE REVISION, WITH NO OTHER PATIENT HARM REPORTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bruise/Contusion
MAUDE report 19209443 ↗InjuryApr 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) WEEKS AGO. SUBSEQUENTLY, THE PATIENT WAS SEEN BY THEIR SURGEON THREE (3) WEEKS LATER AND IT WAS DISCOVERED THAT THE IMPLANTS HAD DISASSOCIATED. THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY THREE WEEKS AGO.
Patient problems: Joint Dislocation
MAUDE report 19132999 ↗InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY NINE (9) MONTHS AFTER THE INITIAL IMPLANTATION TO RECEIVE A PMI DEVICE DUE TO CHRONIC DISLOCATION. IT WAS NOTED THE PATIENT HAD ALSO PREVIOUSLY UNDERWENT TWO PRIOR REVISIONS DUE TO EXPERIENCING DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation; Joint Impingement
MAUDE report 19116337 ↗InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED BY THE PMI GROUP THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY TWO (2) MONTHS POST-IMPLANTATION DUE TO DISLOCATION CAUSED BY THE HUMERAL COMPONENT COMING IN CONTACT WITH THE VRS. DURING THE PROCEDURE, THE POLY WAS EXCHANGED AND THE GLENOSPHERE AND VRS COMPONENTS REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation; Joint Impingement
MAUDE report 19116295 ↗InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED BY THE PMI GROUP THAT A PATIENT UNDERWENT THEIR SECOND REVISION APPROXIMATELY FIVE (5) MONTHS POST-IMPLANTATION DUE TO CHRONIC DISLOCATION CAUSED BY THE HUMERAL COMPONENT COMING IN CONTACT WITH THE VRS. DURING THIS PROCEDURE, THE POLY AND GLENOSPHERE WERE EXCHANGED AND THE VRS COMPONENT REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation; Joint Impingement
MAUDE report 19116203 ↗InjuryMar 10, 2024Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteopenia/ Osteoporosis
MAUDE report 18872230 ↗MalfunctionJan 31, 2024Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information
IT WAS REPORTED PATIENT HAS BEEN INDICATED FOR REVISION DUE TO UNKNOWN REASONS. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 18612776 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K152754, K202232. One submission often covers many models, so check the product and lot details in each record.
- Z-2300-2020 · May 11, 2020 · TerminatedComprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)008803048
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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