Comprehensive Reverse Shoulder 115330Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00880304475342), received between Nov 3, 2019 and May 5, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).

24 other recalls cover devices cleared under the same FDA submission (K080642, K120121, K193373, K992367); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2025Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A SHOULDER SYSTEM. IMAGING TAKEN AFTER THE SURGERY SHOWED LOOSENING AND DISLOCATION OF THE GLENOSPHERE. SUBSEQUENTLY, THE PATIENT WAS REVISED 5 (FIVE) DAYS LATER; THE GLENOSPHERE AND TAPER ADAPTER WERE REMOVED AND REPLACED. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 21961151 ↗
• InjuryJun 25, 2024Unstable; Unstable

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

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain

  MAUDE report 19606535 ↗
• InjuryApr 4, 2024Malposition of Device; Malposition of Device

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS ALSO REVISED FOR INSTABILITY.

  Patient problems: Erosion; Extraskeletal ossification; Inflammation; Pain; Synovitis

  MAUDE report 19047364 ↗
• InjuryNov 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT WAS REVISED A SECOND TIME APPROXIMATELY 2 MONTHS AGO DUE TO DISASSOCIATION. AT THAT TIME THE BASEPLATE AND SCREWS WERE TAKEN OUT ALONG WITH THE TAPER AND GLENOSPHERE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18119136 ↗
• InjuryNov 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT UNDERWENT A SHOULDER PROCEDURE ABOUT 3 MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISASSOCIATION ABOUT 2 WEEKS LATER. THE GLENOSPHERE WAS REVISED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 18118664 ↗
• InjuryNov 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 18049412 ↗
• InjurySep 19, 2022Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT PATIENT WAS REVISED APPROXIMATELY ONE (1) YEAR AND TWO (2) MONTHS POST-IMPLANTATION DUE TO NO FIXATION OF THE BASEPLATE AND TWO (2) FRACTURED SCREWS. DURING THE PROCEDURE, THE BASEPLATE, GLENOSPHERE, POLY AND SCREWS WERE REMOVED AND PATIENT WAS CONVERTED TO A HEMI SHOULDER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Erosion

  MAUDE report 15445749 ↗
• InjuryMar 2, 2022Material Erosion; Loosening of Implant Not Related to Bone-Ingrowth; Material Erosion; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, IN AN UNKNOWN TIMEFRAME POST-IMPLANTATION, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING WITH PERIPROSTHETIC OSTEOLYSIS, WEAR OF THE POLY COMPONENT, AND METALLOSIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 13653535 ↗
• InjuryJan 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A THIRD REVISION DUE TO IMPLANT DISASSEMBLY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 13358434 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

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

  Patient problems: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 11292709 ↗
• InjuryApr 16, 2020Detachment 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: Joint Dislocation

  MAUDE report 9969201 ↗
• InjuryJan 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED PATIENT SUFFERED PAIN DUE TO DISASSOCIATED PROSTHESIS APPROXIMATELY ONE MONTH POST-IMPLANTATION. DUE TO SHORT NOTICE, REPLACEMENT IMPLANTS AND INSTRUMENTS WERE NOT AVAILABLE. THE SURGEON REATTACHED THE GLENOSPHERE AND HUMERAL BEARING TO BASEPLATE, USED 2 JUGGERKNOTS TO HELP STABILIZE THE SHOULDER. TWO CERCLAGE WIRES WERE ATTACHED TO SITE. PATIENT WILL BE OBSERVED TO SEE HOW HE DOES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Information

  MAUDE report 9558320 ↗
• InjuryNov 3, 2019Adverse 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: Pain

  MAUDE report 9270705 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080642, K120121, K193373, K992367. 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-0528-2020 · Aug 21, 2019 · Terminated
  HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA
• 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-1823-2016 · Apr 1, 2016 · Terminated
  Various trauma and sports medicine instruments and implants. Screw, fixation, bone.
• 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-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-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-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 9 more.