Comprehensive® Reverse Shoulder 180554Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
All models of Comprehensive Reverse Shoulder (57)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet Comprehensive Reverse Shoulder implant is a semi-constrained shoulder replacement used in shoulder arthroplasty. The 28 reports mostly describe fractures around the implant — bone breaks and broken or sheared screws and locking pins — along with loosening of the implant and the need for revision surgery to remove or replace components, sometimes leaving a screw fragment behind. No deaths were reported, and all 28 reports were classified as injuries. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00880304677173), received between Jun 9, 2022 and May 4, 2026 — classified as 28 injuries.
The most frequently reported specific device problem is “Fracture” (19 reports).
19 other recalls cover devices cleared under the same FDA submission (K080642, K130390, K132239); 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture19
- Loosening of Implant Not Related to Bone-Ingrowth5
- Adverse Event Without Identified Device or Use Problem4
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information9
- Failure of Implant7
- No Clinical Signs, Symptoms or Conditions4
- Aseptic loosening3
- Bone Fracture(s)2
- Foreign Body In Patient2
- Inadequate Osseointegration2
- Metal Related Pathology2
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryMay 4, 2026Fracture
IT WAS REPORTED BY THE PMI GROUP THAT A PATIENT UNDERWENT A SHOULDER ARTHROPLASTY THREE (3) YEARS AND SIX (6) MONTHS AGO TO RECEIVE A VRS SHOULDER. SUBSEQUENTLY, THE PATIENT WAS REVISED ON SIX (6) MONTHS POST-IMPLANTATION DUE TO SCREW FRACTURE AND RECEIVED A COMPETITOR BASEPLATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25068497 ↗InjuryJan 21, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 24137329 ↗InjuryOct 28, 2025Loosening 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: Aseptic loosening; Septic loosening; Unspecified Infection
MAUDE report 23405962 ↗InjuryOct 28, 2025Loosening 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: Aseptic loosening; Septic loosening; Unspecified Infection
MAUDE report 23405946 ↗InjuryOct 17, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Medical device site infection; No Clinical Signs, Symptoms or Conditions
MAUDE report 23321506 ↗InjuryMay 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; 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 AND 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: Aseptic loosening
MAUDE report 22101932 ↗InjuryMay 12, 2025Fracture; Fracture
IT WAS REPORTED THE PATIENT WAS REVISED TO TO THE BUMPER LOCKING PIN FRACTURE/SHEERED OFF. THE PATIENT WAS REVISED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22005300 ↗InjuryMar 25, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Foreign Body In Patient; Joint Dislocation; Metal Related Pathology
MAUDE report 21690067 ↗InjuryMar 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 21611308 ↗InjuryJan 22, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21207311 ↗InjuryJan 22, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21207309 ↗InjuryOct 23, 2024Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY TWO AND A HALF YEARS (2.5) YEARS FOLLOWING SHOULDER ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION DUE TO FRACTURED BASEPLATE SCREWS. THE BASEPLATE, GLENOSPHERE, TRAY, BEARING, AND SCREWS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS. THE CASE WAS COMPLETED WITHOUT ANY REPORTED ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20515584 ↗InjuryOct 23, 2024Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY TWO AND A HALF YEARS (2.5) YEARS FOLLOWING SHOULDER ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION DUE TO FRACTURED BASEPLATE SCREWS. THE BASEPLATE, GLENOSPHERE, TRAY, BEARING, AND SCREWS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS. THE CASE WAS COMPLETED WITHOUT ANY REPORTED ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20515495 ↗InjuryOct 23, 2024Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY TWO AND A HALF YEARS (2.5) YEARS FOLLOWING SHOULDER ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION DUE TO FRACTURED BASEPLATE SCREWS. THE BASEPLATE, GLENOSPHERE, TRAY, BEARING, AND SCREWS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS. THE CASE WAS COMPLETED WITHOUT ANY REPORTED ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20515477 ↗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 20346446 ↗InjuryMay 21, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 19363333 ↗InjuryMay 21, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 19362790 ↗InjuryMay 21, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 19362676 ↗InjuryMay 21, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 19362667 ↗InjuryMar 25, 2024Adverse 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: Bone Fracture(s)
MAUDE report 18970101 ↗InjuryMar 25, 2024Adverse 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: Bone Fracture(s)
MAUDE report 18970092 ↗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 17985377 ↗InjuryJun 16, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 17143660 ↗InjuryMay 18, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY NINETEEN MONTHS POST INITIAL PROCEDURE DUE TO FRACTURED SCREWS AND LOOSENING OF BASEPLATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 16952937 ↗InjurySep 1, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A COMPREHENSIVE REVERSE SHOULDER REPLACEMENT ONE OF THE LOCKING PERIPHERAL SCREWS FRACTURED WHILE BEING IMPLANTED INTO THE PATIENT. ON BACKING THE SCREW OUT, IT SHEERED OFF THE HEAD OF THE SCREW. THE REMAINING PART OF THE SCREW WAS NOT ABLE TO BE REMOVED AND WAS SECURED IN THE GLENOID BEHIND THE BASEPLATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 15337132 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K080642, K130390, K132239. One submission often covers many models, so check the product and lot details in each record.
- Z-1131-2021 · Jan 15, 2021 · TerminatedCentral Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
- Z-0619-2021 · Nov 25, 2020 · TerminatedComprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 1805
- Z-2144-2020 · Apr 17, 2020 · TerminatedExtremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comp
- Z-1750-2020 · Mar 13, 2020 · TerminatedComprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the gle
- Z-1859-2017 · Feb 17, 2017 · Terminatedvarious polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Sh
- Z-1103-2017 · Dec 20, 2016 · TerminatedComprehensive Reverse Shoulder System Humeral Tray Model 115340
- Z-1548-2013 · May 15, 2013 · TerminatedSuperior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
- Z-2543-2011 · Apr 22, 2011 · TerminatedComprehensive reverse shoulder humeral tray with locking ring, 44 mm +10 mm, sterile, single use, REF 115348, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Should
- Z-2550-2011 · Apr 22, 2011 · TerminatedCustom comprehensive reverse shoulder bio-modular base 44 mm humeral tray standard, REF CP561510, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder product
- Z-2546-2011 · Apr 22, 2011 · TerminatedCustom bi-angular to reverse shoulder humeral tray 44 mm sterile, REF CP561548, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are indicated fo
- Z-2545-2011 · Apr 22, 2011 · TerminatedComprehensive reverse shoulder humeral tray with locking ring, 44 mm standard, sterile, single use, REF 115340, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Sho
- Z-2542-2011 · Apr 22, 2011 · TerminatedBio-modular reverse shoulder humeral tray with lock ring, 44 mm standard, sterile, single use, REF 11-113680, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder
- Z-2548-2011 · Apr 22, 2011 · TerminatedCustom biomodular humeral tray 44 mm sterile, REF CP561686, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients who
- Z-2547-2011 · Apr 22, 2011 · TerminatedCustom solar comprehensive reverse humeral tray with lock ring 44 mm +5mm, sterile, REF CP561659, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder product
- Z-2544-2011 · Apr 22, 2011 · TerminatedComprehensive reverse shoulder humeral tray with locking ring, 44 mm +5 mm, sterile, single use, REF 115345, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulde
…and 4 more.
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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 16, 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