Comprehensive® Reverse Shoulder 180555Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00880304677180), received between Dec 1, 2020 and May 4, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Fracture” (10 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 13 most recent of 13 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 25068503 ↗
• InjuryOct 17, 2025Fracture; Fracture

  INITIAL RIGHT REVERSE TOTAL SHOULDER PERFORMED ON AN UNKNOWN DATE. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO BASEPLATE SCREWS BEING BROKEN, ALL IMPLANTS WERE EXPLANTED, AND A GLENOID BONE GRAFT APPLIED. SPACER WAS IMPLANTED DURING THE REVISION, SUSPECTED POSSIBLE INFECTION. PATIENT WILL BE REIMPLANTED AT A LATER DATE. GLENOSPHERE WAS ALSO NOTED TO BE SUPERIORLY INCLINED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Medical device site infection; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321522 ↗
• 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 22101929 ↗
• InjuryMay 16, 2025Fracture; Fracture

  IT WAS REPORTED THE PATIENT WAS UNDERGOING A RIGHT SHOULDER IMPLANT AND WHILE IMPLANTING A PERIPHERAL SCREW, THE PHYSICIAN COULDN¿T SCREW CLOCKWISE OR COUNTERCLOCKWISE, AND THE HEAD OF THE SCREW FRACTURED. THE REST OF THE SCREW WAS FAR ENOUGH IN AND IT REMAINED IMPLANTED ON THE PATIENT. THERE IS NO PLAN TO REMOVE THE FRACTURED SCREW AT THIS TIME. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22040031 ↗
• 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 20711762 ↗
• 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 20346750 ↗
• 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 19606507 ↗
• InjuryJul 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECOND STAGE REVISION PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO FRACTURED SCREWS APPROXIMATELY FOUR (4) MONTHS POST-IMPLANTATION.

  Patient problems: Failure of Implant

  MAUDE report 17324312 ↗
• InjuryJun 16, 2023Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 17143672 ↗
• InjuryMay 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT UNDERWENT A REVISION SURGERY OVER A YEAR AND A HALF AGO DUE TO FRACTURED SCREWS. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO FRACTURED VRS SCREWS. PATIENT WAS IMPLANTED WITH A SHOULDER HEMI. THIS IS THE THIRD REVISION SURGERY AND SECOND SURGERY DUE TO FRACTURING OF IMPLANTS.

  Patient problems: Failure of Implant

  MAUDE report 17031056 ↗
• InjuryAug 3, 2021Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 12267196 ↗
• InjuryAug 3, 2021Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 12267190 ↗
• InjuryDec 1, 2020Fracture; Difficult to Insert; Fracture; Difficult to Insert

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

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10927122 ↗

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-2545-2011 · Apr 22, 2011 · Terminated
  Comprehensive reverse shoulder humeral tray with locking ring, 44 mm standard, sterile, single use, REF 115340, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Sho
• 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-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-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-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-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
• 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

…and 4 more.