Comprehensive® Reverse Shoulder 180556Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304677197), received between May 29, 2020 and Nov 18, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 20708610 ↗
• 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 17324350 ↗
• 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 17031043 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND STIFFNESS. THE GLENOSPHERE, HUMERAL POLY, TRAY AND BASEPLATE SCREW WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Pain

  MAUDE report 14688902 ↗
• InjuryJun 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 10 MONTHS POSTIMPLANTATION DUE TO IMPINGEMENT OF THE GLENOSPHERE AND CUSTOM GLENOID. GLENOSPHERE AND VRS WERE REMOVED AND THE TRAY AND BEARING SWAPPED WITH A VERSADIAL HEAD. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14643924 ↗
• InjuryJun 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 10 MONTHS POSTIMPLANTATION DUE TO IMPINGEMENT OF THE GLENOSPHERE AND CUSTOM GLENOID. GLENOSPHERE AND VRS WERE REMOVED AND THE TRAY AND BEARING SWAPPED WITH A VERSADIAL HEAD. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14643827 ↗
• InjuryMay 29, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED DURING THE IMPLANTATION OF A VRS CUSTOM GLENOID BASEPLATE, ONE OF THE COMPREHENSIVE FIXED LOCKING SCREWS BECAME LOCKED INTO THE BONE AND WAS UNABLE TO BE REMOVED OR ADVANCED WITHOUT STRIPPING THE SCREW HEAD. IT WAS A 45 MM SCREW, AND APPROXIMATELY 5 MM OF IT WAS STICKING OUT OF THE IMPLANT WHEN IT LOCKED IN PLACE. MULTIPLE ZIMMER BIOMET SCREW DRIVERS WERE USED TO REMOVE THE SCREW, AS WELL AS A NEEDLE NOSE VICE GRIP. ULTIMATELY A TREPHINE STYLE REMOVAL TOOL SUCCESSFULLY UNLOCKED AND REMOVED THE SCREW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10101615 ↗

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-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-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-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-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-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-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-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

…and 4 more.