Comprehensive® Reverse Shoulder 115396Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet Comprehensive Reverse Shoulder implant is a cemented shoulder replacement used in shoulder arthroplasty. The 35 adverse event reports mostly describe the implant loosening or failing to bond to bone, bone fracture or erosion around the shoulder socket, and the ball-and-socket joint coming apart or dislocating, sometimes within weeks of surgery and often requiring revision surgery. Reports also mention a central screw that was not seated deeply enough or that later broke. No deaths were reported, and 33 injuries were reported. 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
- 35
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00880304677081), received between Jun 17, 2020 and Sep 25, 2026 — classified as 33 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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, 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
- Adverse Event Without Identified Device or Use Problem8
- Fracture8
- Loosening of Implant Not Related to Bone-Ingrowth8
- Positioning Failure4
- Detachment of Device or Device Component3
- Device Dislodged or Dislocated2
- Malposition of Device2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Failure of Implant12
- Pain8
- Joint Dislocation7
- Insufficient Information4
- Erosion3
- Metal Related Pathology3
- No Clinical Signs, Symptoms or Conditions3
- Osteopenia/ Osteoporosis3
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Detachment of Device or Device Component
Patient problems: Pain
MAUDE report 50904230 ↗InjuryJul 3, 2026Positioning Failure; Malposition of Device
IT WAS REPORTED THE PATIENT UNDERWENT A REVERSE SHOULDER REVISION PROCEDURE; APPROXIMATELY 43 DAYS POST-IMPLANTATION DUE TO COMPONENT DISLOCATION. THE PATIENT EXPERIENCED A FALL. THE SURGEON NOTED THAT DURING THE INITIAL PROCEDURE, THE CENTRAL SCREW WAS LIKELY PROUD. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 25703448 ↗InjuryJun 4, 2026Positioning Failure
IT WAS REPORTED THAT THE GLENOSPHERE HEAD BECAME DISLODGED FOLLOWING A SHOULDER ARTHROPLASTY, NECESSITATING REOPERATION APPROXIMATELY THREE MONTHS POST-IMPLANTATION. DURING POSTOPERATIVE FOLLOW-UP, THE DISLODGEMENT WAS IDENTIFIED, AND DURING THE REOPERATION THE CENTRAL SCREW WAS RETIGHTENED AND THE GLENOSPHERE HEAD WAS REINSERTED. THE REPORTED CAUSE WAS THAT THE CENTRAL SCREW HAD NOT BEEN INSERTED TO A SUFFICIENT DEPTH DURING THE INITIAL SURGERY. THE PATIENT UNDERWENT REOPERATION WITH SUCCESSFUL COMPLETION OF THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 25391145 ↗InjuryNov 4, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL IMPLANTATION APPROXIMATELY ONE (1) MONTH AGO. SUBSEQUENTLY, IMMEDIATE POST-OP X-RAYS REVEALED DISASSOCIATION OF THE GLENOSPHERE AND A REVISION SURGERY WAS PERFORMED THE SAME DAY. DURING THE REOPERATION, WHEN THE CENTRAL SCREW GUIDE WAS PLACED AGAINST THE BASEPLATE, A GAP WAS OBSERVED THAT CONFIRMED THE CENTRAL SCREW HAD NOT BEEN SUFFICIENTLY INSERTED DURING THE INITIAL IMPLANTATION. THEREFORE, THE CENTRAL SCREW WAS ROTATED 2-3 TURNS AND INSERTED FULLY. AFTER CONFIRMING THE CENTRAL SCREW GUIDE NO LONGER HAD A GAP, THE GLENOSPHERE WAS REPOSITIONED. THE REOPERATION WAS COMPLETED WITHOUT ISSUE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23467064 ↗InjuryOct 3, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY 11.5 MONTHS POST-IMPLANTATION DUE TO A BROKEN CENTRAL SCREW. THE GLENOID WAS REVISED TO A COMPREHENSIVE GLENOID COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23208254 ↗InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY ELEVEN (11) MONTHS AGO. SUBSEQUENTLY, THERE HAS BEEN AN ALLEGED UNKNOWN COMPLICATION WITH NO KNOWN INTERVENTION TO DATE. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 22370775 ↗InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT MATCH IMPLANT (PMI) GROUP THAT THE PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT DUE TO GLENOID FRACTURE/EROSION. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Bone Fracture(s); Erosion
MAUDE report 21961679 ↗InjuryApr 24, 2025Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY APPROXIMATELY TEN (10) MONTHS AGO. SUBSEQUENTLY, APPROXIMATELY SIXTEEN (16) DAYS AFTER THE PATIENT'S INITIAL SURGERY THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE DISLOCATION OF THE IMPLANTS. DURING THE REVISION SURGERY IT WAS DETERMINED BY THE SURGEON THAT THE CENTRAL SCREW WAS NOT FULLY SEATED.
Patient problems: Joint Dislocation
MAUDE report 21899789 ↗InjuryApr 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY FIVE (5) YEARS AND THREE MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY A MONTH AGO DUE TO LOOSENING OF THE IMPLANTS. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 21861262 ↗InjuryMar 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION AND IT WAS NOTED DURING THE REVISION THAT THE POLYETHYLENE BEARING WAS ALSO WORN OUT. THE GLENOSPHERE AND BEARING WERE REMOVED AND REPLACED. THERE WAS HARM OR INJURY TO PATIENT AS THE PATIENT HAD TO UNDERWENT ADDITIONAL SURGICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 21718105 ↗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 21351610 ↗InjuryJan 14, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE PATIENT WAS REVISED FOUR MONTHS POST INITIAL IMPLANTATION DUE TO DISASSOCIATION OF THE GLENOSPHERE. DURING REVISION, THE CENTRAL SCREW WAS FOUND TO BE INSUFFICIENTLY SEATED AND WAS REVISED. EXTRA BONY OSTEOPHYTES WERE CLEARED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Joint Dislocation
MAUDE report 21147919 ↗InjuryJan 7, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT UNDERWENT A SHOULDER ARTHROPLASTY APPROXIMATELY ONE MONTH AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED 8 DAYS LATER DUE TO INSTABILITY AND LOOSENING. PATIENT HAD NEW STEM AND TAPER PUT IN. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 21095590 ↗MalfunctionNov 25, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20773338 ↗InjuryNov 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 20611826 ↗InjuryNov 5, 2024Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION. DURING THE REVISION PROCEDURE, IT WAS OBSERVED THAT THE SCREW WAS NOT FULLY SEATED FROM THE INITIAL PROCEDURE. THERE WAS HARM OR INJURY TO PATIENT AS THE PATIENT HAD TO UNDERWENT ADDITIONAL SURGICAL/MEDICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Inadequate Osseointegration
MAUDE report 20609961 ↗InjuryOct 28, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN DUE TO THE REPORTED EVENT.
Patient problems: Failure of Implant; Pain
MAUDE report 20545606 ↗InjuryJul 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD RIGHT SHOULDER SURGERY IN 2022 FOR UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19799898 ↗MalfunctionJul 10, 2024Difficult to Insert; Difficult to Insert
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19713230 ↗InjuryJun 25, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain
MAUDE report 19606532 ↗InjuryMay 21, 2024Fracture; Fracture
IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY TWO AND HALF YEARS POST-INITIAL IMPLANTATION DUE TO SCREWS AND BASEPLATE FRACTURE. CULTURES WERE POSITIVE FOR C. ACNES AND MRSE, AND PATIENT PLACED ON ANTIBIOTIC REGIMEN. THE PATIENT REMAINS IN CHRONIC PAIN AND RIGHT ARM WEAKNESS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Bacterial Infection; Failure of Implant; Pain
MAUDE report 19358839 ↗InjuryDec 22, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 18382688 ↗InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL IMPLANTATION APPROXIMATELY ONE (1) YEAR AND FOUR (4) MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS EXPERIENCING FLUID COLLECTION IN THE SHOULDER AND UNDERWENT A WASHOUT APPROXIMATELY TWO (2) MONTHS AGO. DURING THE WASHOUT, THE SURGEON NOTED METALLOSIS, WHICH WAS LATER CONFIRMED WITH A CULTURE TEST. THERE WAS ALSO NOTE OF BASEPLATE FAILURE. THE PATIENT LATER UNDERWENT A REVISION APPROXIMATELY THREE (3) WEEKS AGO TO REMOVE THE IMPLANTS. MEDICAL IMAGES WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL AND IDENTIFIED DISASSOCIATION OF THE BASEPLATE, IMPLANT FRACTURE, AND OSTEOPENIC BONE QUALITY.
Patient problems: Metal Related Pathology; Osteopenia/ Osteoporosis; Synovitis
MAUDE report 17985394 ↗InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT A PROCEDURE APPROXIMATELY 4 YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED ABOUT A MONTH AGO DUE TO PAIN, REACTIVE TISSUE, FLUID IN THE CAPSULE, AND TISSUE BETWEEN THE BASEPLATE AND GLENOSPHERE. THERE IS POSSIBLE METALLOSIS OR ALLERGY. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain
MAUDE report 17643914 ↗InjuryJul 31, 2023Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 17427799 ↗
Other prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices
- Comprehensive Reverse Shoulder 115310Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death99 reports
- INHANCE 5120-00-110Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented75 reports
- Comprehensive® Reverse Shoulder XL-115364Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall7 reports
- Comprehensive® Reverse Shoulder XL-115366Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall4 reports
- Comprehensive® Reverse Shoulder 180550Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 deaths43 reports
- Comprehensive® Reverse Shoulder 180551Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- DJO SURGICAL 521-07-246Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® 110031399Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death36 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page