Comprehensive Reverse Shoulder 115313Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00880304475779), received between Aug 10, 2020 and Sep 24, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Device Dislodged or Dislocated

  It was reported the patient underwent a reverse shoulder procedure. Subsequently, the patient had a revision procedure due to glenosphere dislocation approximately one month after surgery. Attempts have been made, and no further information has been provided.

  Patient problems: Joint Dislocation

  MAUDE report 50884332 ↗
• InjuryAug 4, 2026Detachment of Device or Device Component

  It was reported that a revision of a reverse total shoulder arthroplasty was performed on the right shoulder due to recurrent dislocation of the glenosphere from the glenoid baseplate. The construct had been in place for approximately five (5) months and three (3) weeks. The glenosphere, the taper adaptor, the humeral tray, and the humeral bearing were removed. The construct was converted to a hemiarthroplasty with a larger humeral head. The glenoid baseplate and the screws were not removed. No additional consequences to the patient were reported. Attempts have been made and no further information has been provided.

  Patient problems: Joint Dislocation

  MAUDE report 50127188 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient underwent a right total reverse shoulder arthroplasty and subsequently required a revision approximately 4 weeks post-implantation due to instability. Attempts have been made and no further information has been provided.

  Patient problems: Joint Laxity

  MAUDE report 50114822 ↗
• InjuryMar 16, 2026Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening; Pain

  MAUDE report 24605786 ↗
• InjuryNov 19, 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 LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) YEARS AND TWO (2) MONTHS AGO AS PART OF A CLINICAL STUDY. SUBSEQUENTLY, THE PATIENT DEVELOPED TENDONITIS APPROXIMATELY ONE (1) YEAR AND FOUR (4) MONTHS POST-IMPLANTATION AND WAS TREATED WITH STEROID INJECTIONS AND PHYSICAL THERAPY. THE EVENT WAS NOTED TO HAVE RESOLVED ONE (1) MONTH LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Tendinopathy

  MAUDE report 23596162 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY 15 DAYS POST-IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Arthropathy; Insufficient Information

  MAUDE report 22874320 ↗
• InjuryJun 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY ONE (1) MONTH AGO. SUBSEQUENTLY, THE PATIENT THE PATIENT UNDERWENT A REVISION SURGERY SEVEN (7) DAYS AFTER THEIR INITIAL SURGERY DUE TO DISLOCATION OF THE IMPLANTS. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 22287418 ↗
• InjuryJun 18, 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 22283630 ↗
• InjuryMay 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 MONTHS POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 22077307 ↗
• InjuryMar 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THAT A PATIENT WAS REVISED AGAIN APPROXIMATELY 6 MONTHS POST IMPLANTATION DUE TO RECURRENT DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 21645291 ↗
• InjurySep 13, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOUR MONTHS POST INITIAL IMPLANTATION DUE TO INSTABILITY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 20214691 ↗
• InjuryOct 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SHOULDER ARTHROPLASTY DUE TO A THREE (3) MONTH OLD FOUR (4) PART PROXIMAL HUMERUS FRACTURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY ONE (1) MONTH LATER DUE TO THE IMPLANTS DISLOCATING MULTIPLE TIMES IN AN ANTERIOR POSITION. DURING THE REVISION THE SURGEON REMOVED A LARGE PIECE OF BONE FROM THE ORIGINAL FRACTURE DUE TO THE SURGEON BELIEVING THAT THE PIECE OF BONE WAS CONTRIBUTING TO THE REASON THAT THE IMPLANTS WERE DISLOCATING.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 17948876 ↗
• InjuryMay 12, 2023Unstable; Unstable

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

  Patient problems: Failure of Implant

  MAUDE report 16918391 ↗
• InjuryMar 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 16601426 ↗
• InjuryMar 6, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SURGERY APPROXIMATELY 3 YEARS AGO, SUBSEQUENTLY THE PATIENT HAD A REVISION FOR THE REMOVAL OF THE GLENOSPHERE IMPLANT, DURING THE SURGERY A FRACTURED SCREW WAS PARTIALLY REMOVED; HOWEVER, SOME OF THE SCREW REMAINED IN THE GLENOID. ALSO, THE BACTERIOLOGY WAS POSITIVE FOR CUTI ACNES, BUT NO INTRAOPERATIVE SEPTIC SIGNS, NOR PAIN BEFORE THE BREAKAGE OF THE MATERIAL. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Bacterial Infection; Failure of Implant; Foreign Body In Patient

  MAUDE report 16486644 ↗
• InjuryOct 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT IS INDICATED TO NEED A REVISION PROCEDURE, APPROXIMATELY ONE (1) YEAR POST-IMPLANTATION DUE TO DISLOCATING THEIR SHOULDER WHILE CHANGING A TIRE. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 15690140 ↗
• InjuryApr 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  T WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO IMPLANT FRACTURE CAUSING THE PATIENT'S SHOULDER TO DISLOCATE.

  Patient problems: Joint Dislocation

  MAUDE report 14111112 ↗
• InjuryFeb 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 11321713 ↗
• InjuryAug 10, 2020Unintended Movement; Unintended Movement

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

  Patient problems: Failure of Implant

  MAUDE report 10384702 ↗

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-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-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-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-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-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-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

…and 4 more.