Comprehensive Shoulder System 118000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00880304531048), received between Apr 2, 2020 and Jul 27, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 reports).

22 other recalls cover devices cleared under the same FDA submission (K080642, K120121, K193373, K202232); 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Detachment of Device or Device Component; Unintended Movement

  It was reported that after a reverse shoulder procedure, the patient later required two surgeries due to disengagement of the glenosphere from the reverse baseplate and disassociated.The reporter attributed these occurrences in part to patient non-compliance and to the central screw not being seated sufficiently to allow proper seating of the glenosphere.The patient underwent two revision surgeries and this reported event is covering the second revision surgery.Attempts have been made and no further information has been provided.

  Patient problems: Insufficient Information

  MAUDE report 50038001 ↗
• InjuryMay 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TWO PREVIOUS REVISIONS APPROXIMATELY TWO (2) YEARS AGO FOR DISASSOCIATION AND APPROXIMATELY THREE (3) MONTHS AGO DUE TO DISASSOCIATION. SUBSEQUENTLY, THE PATIENT WAS REVISED A THIRD TIME APPROXIMATELY THREE (3) WEEKS AGO DUE TO DISASSOCIATION OF THE TAPER AND BASEPLATE. DURING THE REVISION, DARK SYNOVIAL STAINING AND EXTENSIVE METAL-COLORED FIBRINOUS MATERIAL, AS WELL AS POLYETHYLENE WEAR WAS NOTED. THE STEM AND BASEPLATE WERE STABLE AND THEREFORE RETAINED, ALL REMAINING IMPLANTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 25323383 ↗
• InjuryDec 31, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A PROCEDURE, A NEW TAPER WAS ATTEMPTING TO BE IMPLANTED INTO THE EXISTING BASEPLATE AND WOULD NOT STAY ENGAGED. AS A RESULT, THE SURGEON DECIDED TO REMOVE THE BASEPLATE AND CONVERT THE PATIENT TO A HEMI-ARTHROPLASTY INSTEAD. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23936887 ↗
• InjurySep 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY SEVEN (7) YEARS AGO. THE PATIENT WAS REVISED APPROXIMATELY SIX (6) YEARS AND TEN (10) MONTHS LATER DUE TO IMPLANT DISASSOCIATION. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO IMPLANT DISASSOCIATION. IT WAS NOTED THE PATIENT WAS EXPERIENCING PAIN AND ROM ISSUES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER EVENT INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 23031614 ↗
• InjuryMar 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TEN MONTHS POST-INITIAL IMPLANTATION DUE TO DISASSOCIATED GLENOSPHERE. THE PATIENT'S GLENOSPHERE, TRAY, BEARING, AND LINER WERE REVISED. DEBRIDEMENT OF THE PERIPHERAL BONE/TISSUE SURROUNDING THE BASEPLATE WAS PERFORMED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 21645028 ↗
• InjuryMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Erosion; Osteopenia/ Osteoporosis; Pain

  MAUDE report 19228199 ↗
• InjuryApr 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Joint Dislocation

  MAUDE report 19132990 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A COMPLEX REVISION HISTORY OF A RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, INCLUDING MULTIPLE PERIPROSTHETIC FRACTURE REPAIRS AND MRSA INFECTION IN THE JOINT. THE PATIENT UNDERWENT AN ADDITIONAL REVISION DUE TO UNKNOWN REASONS. THREE WEEKS LATER, THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT WITH NO REPORTED PRODUCT EXCHANGE. NO MEDICAL RECORDS OR ADDITIONAL INFORMATION HAS BEEN PROVIDED TO FURTHER DETAIL THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18959696 ↗
• InjurySep 12, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISASSOCIATION APPROXIMATELY FOUR YEARS POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 17730160 ↗
• InjuryJun 21, 2023Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY TWO WEEKS POST IMPLANTATION DUE TO DISASSOCIATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17169869 ↗
• InjuryJun 12, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

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

  Patient problems: Fall; Joint Dislocation; Pain

  MAUDE report 17108216 ↗
• InjuryJun 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO DISASSOCIATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 14830803 ↗
• InjuryMay 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECOND LEFT SHOULDER REVISION SURGERY DUE TO IMPLANTS DISASSOCIATING. THE PATIENT WAS IN RECOVERY FROM THEIR FIRST REVISION SURGERY WHEN THE IMPLANTS DISASSOCIATED.

  Patient problems: Failure of Implant

  MAUDE report 14349025 ↗
• InjuryMar 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT SHOULDER PROCEDURE APPROXIMATELY A 5 WEEKS AGO. SUBSEQUENTLY, PATIENT WAS REVISED DUE TO DISASSOCIATION ABOUT 3 WEEKS LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 11590619 ↗
• InjuryApr 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 9915425 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080642, K120121, K193373, K202232. 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-1615-2020 · Feb 25, 2020 · Terminated
  Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain a
• Z-0972-2019 · Dec 21, 2018 · Terminated
  Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use i
• 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-1208-2015 · Jan 7, 2015 · Terminated
  Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400
• 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-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-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-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-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 7 more.