Comprehensive® Reverse Shoulder XL-115365Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304475519), received between Jan 21, 2020 and Mar 4, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A STAGE-TWO REVISION RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. THE PATIENT UNDERWENT AN ADDITIONAL REVISION WITH A NICKEL FREE PROSTHESIS SIX (6) MONTHS AFTER THE REVISION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18827683 ↗
• InjuryNov 10, 2022Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT SHOULDER REVISION SURGERY APPROXIMATELY ONE (1) WEEK AFTER UNDERGOING AN INITIAL REVISION SURGERY DUE TO AN UNKNOWN REASON.

  Patient problems: Failure of Implant; Insufficient Information; Joint Dislocation

  MAUDE report 15770645 ↗
• InjuryFeb 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE SHOULDER PROCEDURE AND SUBSEQUENTLY EXPERIENCED A SHOULDER DISLOCATION. IT IS UNKNOWN WHAT CAUSED THE DISLOCATION. NO REVISION PROCEDURE HAS BEEN INDICATED AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 13479777 ↗
• InjuryApr 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 11697464 ↗
• InjuryJan 21, 2020Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

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

  Patient problems: Failure of Implant

  MAUDE report 9612463 ↗

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, 180562
• 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 th
• 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-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-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-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
• 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.