Comprehensive Reverse Shoulder 115310Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 00880304475373), received between Nov 11, 2019 and Sep 30, 2026 — classified as 1 death, 96 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (50 reports).

19 other recalls cover devices cleared under the same FDA submission (K080642, K193373); 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 99 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 50948320 ↗
• InjurySep 23, 2026Device Dislodged or Dislocated

  It was reported that the patient underwent an initial implantation approximately one (1) month ago with the Identity RSA system. During the implantation, there was a noted instability during the procedure, the surgeon confirmed that it had not dislocated and concluded the surgery. Subsequently, the patient repeatedly dislocated after the surgery and a revision was performed approximately one (1) week post-implantation. Attempts have been made and no further information has been provided.

  Patient problems: Joint Dislocation

  MAUDE report 50872937 ↗
• InjurySep 15, 2026Detachment of Device or Device Component

  It was reported that following an initial reverse total shoulder arthroplasty, radiography performed after the procedure showed that the glenosphere had become dislodged/detached. The incision was reopened, and reinsertion of the glenosphere was attempted. The taper did not fit, and the central screw was retightened. The procedure was completed with a replacement taper adapter and a replacement glenosphere. Attempts have been made, and no further information has been provided.

  Patient problems: Insufficient Information

  MAUDE report 50769824 ↗
• InjurySep 10, 2026Device Dislodged or Dislocated; Noise, Audible

  It was reported that a disassociation/dislocation occurred approximately two months after implantation of a right reverse total shoulder arthroplasty. The patient reported a clicking sensation and a feeling that something was "off" prior to presentation. The patient underwent revision, during which the polyethylene bearing was exchanged. No patient injury, sequelae, or outcome was reported beyond the disassociation/dislocation and the revision procedure. The surgical technique used during the initial procedure was indicated to have been followed. Attempts have been made, and no further information has been provided.

  Patient problems: Crepitus; Joint Dislocation

  MAUDE report 50706912 ↗
• InjuryApr 13, 2026Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Dislocation

  MAUDE report 24857585 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY THREE (3) YEARS POST-IMPLANTATION DUE TO LIMITED RANGE OF MOTION. DURING THE REVISION, THE TRAY AND BEARING WERE REVISED IN ORDER TO INCREASE THE OFFSET AMOUNT AND THE GLENOSPHERE REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion

  MAUDE report 24745223 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT REVERSE TOTAL SHOULDER PROCEDURE AND SUBSEQUENTLY UNDERWENT A RIGHT SHOULDER BIOPSY WITH POSSIBLE POLYETHYLENE LINER EXCHANGE. AS IT IS UNKNOWN WHAT THE REASON FOR REVISION WAS, ALL IMPLANTS ARE INCLUDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24688501 ↗
• InjuryMar 18, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY ONE (1) MONTH POST-IMPLANTATION DUE TO DISLOCATION. THE BEARING WAS REVISED AND THE GLENOSPHERE REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 24628523 ↗
• InjuryMar 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT UNDERWENT A BEARING EXCHANGE APPROXIMATELY THREE AND A HALF (3.5) MONTHS POST-IMPLANTATION DUE TO A DISLOCATION THAT WAS IDENTIFIED DURING ROUTINE REVIEW. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 24545414 ↗
• InjuryFeb 9, 2026Malposition of Device

  IT WAS REPORTED THE PATIENT EXPERIENCED IMPINGEMENT AND PAIN DUE TO IMPLANT MALPOSITION AND UNDERWENT REVISION APPROXIMATELY 17 MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Impingement; Pain

  MAUDE report 24291774 ↗
• InjuryJan 13, 2026Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 24058303 ↗
• InjuryDec 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 23830062 ↗
• InjuryDec 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 23767512 ↗
• InjuryDec 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Fall; Joint Dislocation

  MAUDE report 23761025 ↗
• InjuryDec 2, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN UNKNOWN SHOULDER REVISION FOR UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696594 ↗
• InjuryNov 24, 2025Adverse 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 Notching; Pain

  MAUDE report 23639439 ↗
• InjuryOct 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s); Bone Notching; Joint Dislocation; Loss of Range of Motion; Muscle Weakness/Atrophy; Nonunion/Delayed-union Bone Fracture; Osteolysis; Pain; Unequal Limb Length

  MAUDE report 23378778 ↗
• InjuryOct 24, 2025Mechanical Jam; Mechanical Jam

  ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Impingement; Loss of Range of Motion; Pain

  MAUDE report 23378345 ↗
• InjuryOct 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 23357611 ↗
• InjuryJul 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT HAD A PRIMARY SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY 3 YEARS LATER, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A DISLOCATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 22664513 ↗
• InjuryJul 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 22608972 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A SHOULDER REVISION DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 22576521 ↗
• InjuryJul 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT HAD A PRIMARY REVERSE SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY 11 DAYS LATER, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A DISLOCATED POLY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 22538119 ↗
• 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 22530354 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY ELEVEN (11) MONTHS AGO. SUBSEQUENTLY, THERE HAS BEEN AN ALLEGED UNKNOWN COMPLICATION WITH NO KNOWN INTERVENTION TO DATE. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22370773 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080642, K193373. One submission often covers many models, so check the product and lot details in each record.

• 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-0093-2021 · Sep 2, 2020 · Terminated
  Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for t
• 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-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-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-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-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-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-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-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.