Comprehensive® Reverse Shoulder 180553Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00880304677166), received between Nov 13, 2019 and Jan 21, 2026 — classified as 1 death, 45 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2026Fracture

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

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 24137330 ↗
• InjuryOct 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Aseptic loosening; Septic loosening; Unspecified Infection

  MAUDE report 23405963 ↗
• InjurySep 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RSA USING A VRS ON APPROXIMATELY TWO (2) YEARS AND TWO (2) MONTHS AGO. SUBSEQUENTLY, THE PATIENT CAME INTO THE HOSPITAL ON AN UNKNOWN DATE APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS POST-IMPLANTATION COMPLAINING OF PAIN IN THE AFFECTED AREA. AN X-RAY REVEALED THAT THE LOWER SCREW OF THE BASEPLATE HAD FRACTURED. AT THE TIME, IT DID NOT APPEAR THAT THERE WAS LOOSENESS IN THE BASEPLATE, AND NO BONE FRACTURE SITE HAS BEEN IDENTIFIED. THE PATIENT LATER UNDERWENT A REVISION SURGERY APPROXIMATELY TWO (2) YEARS POST-IMPLANTATION WHERE THE VRS GLENOID COMPONENT WAS NOTED TO NOT BE INTEGRATED WITH THE BONE AND WAS FLOATING. ALL FRACTURED SCREWS WERE REMOVED USING A REMOVAL KIT. THE STEM REMAINED STABLE, SO THE STEM, TRAY, AND LINER WERE LEFT IN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 23110435 ↗
• 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 22530370 ↗
• InjuryJul 16, 2025Loosening 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: Pain

  MAUDE report 22524270 ↗
• 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 22101934 ↗
• 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 22101933 ↗
• 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 21961680 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM A CLINICAL STUDY THAT A PATIENT HAD A RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY PERFORMED APPROXIMATELY 5.5 YEARS AGO. THE PATIENT DID VERY WELL THROUGHOUT THE STUDY UNTIL REPORTING SEVERE PAIN AND INSTABILITY WITH ACTIVITIES AT THE 5 YEAR FOLLOW UP. NO TREATMENT OR INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 21734205 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM A CLINICAL STUDY THAT A PATIENT HAD A RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY PERFORMED APPROXIMATELY 5.5 YEARS AGO. THE PATIENT DID VERY WELL THROUGHOUT THE STUDY UNTIL REPORTING SEVERE PAIN AND INSTABILITY WITH ACTIVITIES AT THE 5 YEARS FOLLOW UP. NO TREATMENT OR INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 21734200 ↗
• 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 21611289 ↗
• 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 21611284 ↗
• InjuryJan 22, 2025Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 21207314 ↗
• 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 21095595 ↗
• InjuryNov 18, 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 20711174 ↗
• 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 20515497 ↗
• 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 20346436 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS REVISED DUE TO FRACTURE OF THE GLENOID AND DISLOCATION OF THE BEARING AND GLENOPSHERE APPROXIMATELY 5 MONTHS POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 20051855 ↗
• InjuryAug 22, 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 20043078 ↗
• InjuryJul 22, 2024Insufficient 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 19802572 ↗
• InjuryJul 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 5 MONTHS POST IMPLANTATION DUE TO LOOSENING AND FRACTURED SCREWS. THE BASEPLATE, TRAY, GLENOSPHERE AND SCREWS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 19655167 ↗
• InjuryJul 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 5 MONTHS POST IMPLANTATION DUE TO LOOSENING AND FRACTURED SCREWS. THE BASEPLATE, TRAY, GLENOSPHERE AND SCREWS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 19655160 ↗
• InjuryMay 21, 2024Fracture; Fracture

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

  Patient problems: Bacterial Infection; Failure of Implant; Pain

  MAUDE report 19358841 ↗
• 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 19116215 ↗
• 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 19062165 ↗

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-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-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-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-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-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
• 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-2541-2011 · Apr 22, 2011 · Terminated
  Bio-modular reverse shoulder humeral tray with lock ring, 44 mm 10 degree angle, sterile, single use, REF 11-113685, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse S

…and 4 more.