Comprehensive® Reverse Shoulder 115340Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00880304475335), received between Jan 9, 2020 and Jul 30, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Separation Problem

  It was reported that the patient underwent a revision of a left reverse total shoulder arthroplasty due to subluxation. It was reported that the glenosphere had dislocated. During the revision, the polyethylene insert was reported to show partial wear and was removed, and overgrowth of scar tissue at the glenoid baseplate was removed. The glenoid baseplate was reported to be integrated and was retained, and a replacement glenosphere was secured to it. The humeral cup was reported to be well fixed, and when the insert could not be placed without difficulty the humeral cup was removed and its taper was reported to be altered. The glenosphere, taper adaptor, humeral bearing and humeral tray were reported to have been explanted and replaced, and the humeral stem was retained. The components were reported to provide good range of motion and to be stable and well fixed, and closure was reported without complications. Due diligence is complete for this complaint; it was reported that no further information is available, and to date no additional information or product has been received.

  Patient problems: Joint Dislocation; Scar Tissue; Subluxation

  MAUDE report 50093580 ↗
• InjuryJul 28, 2026Fracture; Noise, Audible

  It was reported that the patient underwent a revision of a left reverse total shoulder arthroplasty. It was reported that the patient had a history of prior revisions of the same shoulder construct. The reported reason for the current revision was a fracture of the humeral tray, occurring approximately 6.5 years post-implantation, which the patient described as a metallic snap while putting on a jacket, after which the patient presented to the clinic. It was reported that during the revision, the taper could not be removed from the humeral shaft, so the taper junction and humeral components were explanted and exchanged. No additional patient harm was reported. Due diligence is in progress for this complaint; to date no additional information or product has been received.

  Patient problems: Insufficient Information

  MAUDE report 50056830 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM A CLINICAL STUDY THAT A PATIENT HAD AN LEFT TOTAL SHOULDER. SUBSEQUENTLY, THE PATIENT HAS REPORTED AN INCREASE IN SHOULDER PAIN, AT TIMES SEVERE, WITH AN ONSET DATE OF APPROXIMATELY 6 YEARS POSTOP. IT IS UNKNOWN IF REVISION SURGERY IS RECOMMENDED OR PLANNED. NO INTRAOPERATIVE COMPLICATIONS. NO FURTHER INFORMATION REGARDING TREATMENT OR INTERVENTION HAS BEEN PROVIDED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 23610462 ↗
• InjuryJul 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS INITIALLY IMPLANTED WITH A TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION DUE TO UNKNOWN REASONS. DURING THE REVISION PROCEDURE, THE SURGEON NOTED THE HUMERAL TRAY WAS FRACTURED AND THE TAPER WOULD NOT DISENGAGE FROM THE STEM. THEREFORE, THE SURGEON REMOVED THE TAPER AND STEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22620980 ↗
• InjuryFeb 18, 2025Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 21401656 ↗
• InjuryMay 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER REVERSE SHOULDER SURGERY AND ARTHROCENTESIS APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS AGO. SUBSEQUENTLY, THE PATIENT APPROXIMATELY TWO (2) WEEKS AGO PRESENTED TO THE HOSPITAL WITH THE IMPLANT FRACTURED CAUSING THE PATIENT'S SHOULDER TO DISLOCATE. THE X-RAYS WERE TAKEN, AND THE SURGEON RECOMMENDED A REVISION SURGERY, BUT THE PATIENT HAS DECIDED TO NOT HAVE THE REVISION SURGERY AT THIS TIME.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19390961 ↗
• InjuryMay 21, 2024Fracture; Fracture

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 19368048 ↗
• 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 18959694 ↗
• InjuryNov 10, 2022No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770593 ↗
• MalfunctionApr 5, 2021Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614803 ↗
• InjuryJan 9, 2020Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THE PATIENT WAS REVISED APPROXIMATELY THREE YEARS POST-IMPLANTATION TO ADDRESS IN-VIVO IMPLANT FRACTURE UPON INVOLUNTARY PATIENT MOVEMENT. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

  Patient problems: No Information

  MAUDE report 9568392 ↗

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-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-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-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
• 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-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-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

…and 4 more.