Comprehensive® VRS™ 110031378Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304834026), received between Apr 8, 2022 and Jan 8, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component4
- Device Dislodged or Dislocated2
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant2
- Pain2
- Bruise/Contusion1
- Erosion1
- Inflammation1
- Insufficient Information1
- Loss of Range of Motion1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2026Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 24007157 ↗InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 21764657 ↗InjuryJan 8, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED TWO WEEKS POST-INITIAL IMPLANTATION DUE TO HEAD DISLOCATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21102363 ↗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 19228195 ↗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 19209312 ↗InjuryJan 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF THE INITIAL VRS DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 18496931 ↗InjuryApr 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE GLENOSPHERE DISASSOCIATED FROM VRS BASEPLATE. DESPITE SUCCESSFUL PATIENT FOLLOW UP APPOINTMENTS AT 3 AND 6 MONTHS POSTOPERATIVELY SHOWING GOOD IMPLANT ALIGNMENT, THE PATIENT WAS SEEN IN THE OFFICE WITH A DISASSOCIATED GLENOSPHERE. THE 36MM GLENOSPHERE AND ITS TAPER ADAPTOR HAD DISLOCATED FROM THE VRS BASEPLATE. UPON REVISION SURGERY, NEW IMPLANTS OF THE SAME DIMENSIONS WERE SUCCESSFULLY PLACED. THE CENTRAL SCREW FROM THE INITIAL SURGERY WAS REMOVED AND NOT REPLACED AT THE REVISION. IT WAS NOTED THAT THE SCREW HEAD MAY HAVE BEEN PROUD OF FULLY SEATED WITHIN THE VRS BOSS WHEN CHECKED WITH THE VRS INSERTER PRIOR TO SCREW REMOVAL. THE VRS INSERTER SAT FLUSH AGAINST THE FACE OF THE VRS IMPLANT AFTER THE CENTRAL SCREW WAS REMOVED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Inflammation; Loss of Range of Motion; Pain
MAUDE report 14053083 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.