Comprehensive® Reverse Shoulder 180552Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00880304677159), received between Nov 5, 2019 and Sep 26, 2026 — classified as 1 death, 44 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2026Detachment of Device or Device Component

  Patient problems: Pain

  MAUDE report 50906502 ↗
• InjurySep 25, 2026Detachment of Device or Device Component

  Patient problems: Pain

  MAUDE report 50904422 ↗
• InjurySep 25, 2026Detachment of Device or Device Component

  Patient problems: Pain

  MAUDE report 50904276 ↗
• InjuryApr 1, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 DAYS POST IMPLANTATION DUE TO A POORLY FIXATED AND LOOSENED CENTRAL SCREW. THE SURGEON STATED THE CENTRAL SCREW WAS TOO SHORT AND NOT BICORTICAL, AND ACCEPTED THIS AS SURGEON ERROR. THE SURGEON ALSO REPORTED THE PATIENT HAD POOR BONE QUALITY AND AVASCULAR NECROSIS, WHICH MAY HAVE CONTRIBUTED TO THE FAILURE, AND WAS UNSURE IF A LONGER BICORTICAL CENTRAL SCREW WOULD HAVE PREVENTED THE LOOSENING FAILURE. THE PATIENT WAS REVISED BY REMOVING THE GLENOID/BASEPLATE AND CONVERTING TO A HEMIARTHROPLASTY. THE HUMERAL STEM REMAINED IN SITU. NO ADDITIONAL PATIENT OUTCOME INFORMATION WAS PROVIDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 24757197 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT REVISION USING A CUSTOM IMPLANT APPROXIMATELY 1 YEAR AND 1 MONTH POST IMPLANTATION DUE TO THE PATIENT'S GLENOID BONE FRACTURING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 24415346 ↗
• InjuryDec 18, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY REVERSE SHOULDER PROCEDURE. SUBSEQUENTLY, APPROXIMATELY 5 MONTHS AND 19 DAYS POST IMPLANTATION THE PATIENT WAS PRESENTING WITH A PAINFUL SHOULDER AND AN X-RAY AND CT SCAN SHOWED GLENOID COMPONENT MIGRATION. IT WAS NOTED THAT THE PATIENT HAD PRIOR NEUROLOGIC PATHOLOGY AND POOR BONE QUALITY. THE PATIENT PLANS TO BE REVISED WHERE THE GLENOID COMPONENTS WILL BE REMOVED WHILE DISCUSSING FURTHER OPTIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 23843684 ↗
• InjuryDec 18, 2025Migration; Migration

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 23843529 ↗
• MalfunctionSep 18, 2025Degraded; Degraded

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085279 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE DISLOCATION. IT WAS NOTED THAT 2 SCREWS WERE ALSO REVISED DUE TO UNKOWNS REASONS. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 22586248 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE DISLOCATION. IT WAS NOTED THAT 2 SCREWS WERE ALSO REVISED DUE TO UNKNOWN REASON. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 22586246 ↗
• DeathJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY IN RECOVERY FOLLOWING A REVERSE TOTAL SHOULDER REPLACEMENT WITH THE COMPREHENSIVE SYSTEM. AS FAR AS THE SURGEON WAS CONCERNED, THE OPERATION WAS COMPLETED AS EXPECTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22530363 ↗
• 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 21961678 ↗
• 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 21961676 ↗
• 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 21961675 ↗
• 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 21690085 ↗
• InjuryFeb 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A LOOSENING OF THE DEVICE. THERE WAS HARM OR INJURY TO PATIENT AS THE PATIENT HAD TO UNDERGO ADDITIONAL SURGICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 21369883 ↗
• InjuryDec 3, 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; Osteopenia/ Osteoporosis

  MAUDE report 20831439 ↗
• InjuryOct 28, 2024Loose or Intermittent Connection; Loosening of Implant Not Related to Bone-Ingrowth; Loose or Intermittent Connection; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN DUE TO THE REPORTED EVENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 20545771 ↗
• InjuryOct 28, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED PATIENT UNDERWENT PRIMARY SHOULDER SURGERY APPROXIMATELY A YEAR AND A HALF AGO. SUBSEQUENTLY, THE GLENOID BECAME LOOSE. THE SUPERIOR SCREWS WERE NOT SEATED IN THE BONE. PATIENT WAS REVISED ABOUT A MONTH AGO. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Failure of Implant; Pain

  MAUDE report 20545682 ↗
• 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 19606518 ↗
• InjuryApr 16, 2024Loosening 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 ONE (1) YEAR AND TWO (2) MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS INDICATED FOR A REVISION WITH PMI PRODUCT DUE TO ALLEGED BASEPLATE LOOSENING. THE REPORTER ALSO NOTED AN APPARENT PROBLEM WITH THE PATIENT'S BONE QUALITY. A REVISION HAS NOT BEEN CONFIRMED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 19116224 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 19062100 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 19035586 ↗
• MalfunctionNov 20, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED, THAT THE CUSTOMER HAD OPENED THE ORIGINAL SEALED BOX AND WENT TO OPEN THE SCREW PACKAGE, BUT NOTICED THE SCREW APPEARS TO BE MELTED TO THE INNER PACKAGING. NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18168941 ↗
• 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 17985403 ↗

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 · Terminated
  Central 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 · Terminated
  Comprehensive 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 · Terminated
  Extremities 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 · Terminated
  Comprehensive 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 · Terminated
  various 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 · Terminated
  Comprehensive Reverse Shoulder System Humeral Tray Model 115340
• Z-1548-2013 · May 15, 2013 · Terminated
  Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
• Z-2544-2011 · Apr 22, 2011 · Terminated
  Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +5 mm, sterile, single use, REF 115345, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulde
• Z-2547-2011 · Apr 22, 2011 · Terminated
  Custom solar comprehensive reverse humeral tray with lock ring 44 mm +5mm, sterile, REF CP561659, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder product
• Z-2550-2011 · Apr 22, 2011 · Terminated
  Custom 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 · Terminated
  Custom 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-2543-2011 · Apr 22, 2011 · Terminated
  Comprehensive 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-2548-2011 · Apr 22, 2011 · Terminated
  Custom 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-2549-2011 · Apr 22, 2011 · Terminated
  Custom comprehensive reverse humeral tray set w/ lock rings 44 mm + 15 mm & + 18 mm sterile, REF CP561705, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder
• Z-2542-2011 · Apr 22, 2011 · Terminated
  Bio-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

…and 4 more.