Comprehensive Reverse Shoulder 115370Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00880304543201), received between Oct 17, 2019 and Mar 25, 2026 — classified as 31 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 reports).

19 other recalls cover devices cleared under the same FDA submission (K080642, K113069, 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A PRIOR RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY SUBSEQUENTLY UNDERWENT A RIGHT SHOULDER BIOPSY WITH POSSIBLE POLYETHYLENE LINER EXCHANGE. AS IT IS UNKNOWN WHAT THE REASON FOR REVISION WAS, ALL IMPLANTS ARE INCLUDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24688463 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 23660836 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Discomfort; Pain

  MAUDE report 23575257 ↗
• InjuryOct 29, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

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

  Patient problems: Pain

  MAUDE report 23412218 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Extraskeletal ossification; Pain; Tendinopathy

  MAUDE report 23100067 ↗
• InjuryAug 8, 2025Fracture; Fracture

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY FOLLOWED BY A REVISION ON APPROXIMATELY 6 YEARS POST-IMPLANTATION DUE TO PAIN. SUBSEQUENTLY, REPORTED AN UNKNOWN IMPLANT BROKE AND UNDERWENT A SECOND REVISION APPROXIMATELY 7 YEARS POSTERIOR. THE BEARING AND HUMERAL TRAY WERE REVISED AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22748410 ↗
• InjuryMay 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A TOTAL SHOULDER ARTHOPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO FRACTURE OF THE HUMERAL TRAY. THERE WAS HARM/INJURY TO THE PATIENT AS THE PATIENT HAD TO UNDERWENT SURGICAL/MEDICAL INTERVENTION. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 22044501 ↗
• InjuryMay 5, 2025Fracture; Noise, Audible; Fracture; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY NINE (9) YEARS AND FIVE (5) MONTHS POST-IMPLANTATION DUE TO EXPERIENCING A FRACTURE OF THE HUMERAL TRAY'S STEM/KNOB. IT WAS NOTED THE PATIENT WAS EXERCISING WHEN THEY HEARD A POP, FOLLOWED BY EXPERIENCING PAIN. IT WAS NOTED BECAUSE THE HUMERAL TRAY'S KNOB WAS FRACTURED OFF INTO THE HUMERAL STEM, THE STEM ALSO HAD TO BE REMOVED, CAUSING THE REVISION TO BE PROLONGED 2 HOURS LONGER THAN ANTICIPATED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 21960021 ↗
• InjuryMar 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 21611279 ↗
• InjurySep 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.

  Patient problems: Failure of Implant

  MAUDE report 20249435 ↗
• InjuryJun 11, 2024Fracture; Fracture

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

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 19509351 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS PRESCRIBED PAIN MEDICATION APPROXIMATELY 2.5 YEARS POST IMPLANTATION OF AN RTSA DUE TO CHRONIC SHOULDER PAIN. ALL DEVICES REMAIN IMPLANTED AND NO FURTHER INTERVENTION HAS OCCURRED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 19035632 ↗
• MalfunctionMar 4, 2024Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED DURING A TOTAL SHOULDER ARTHROPLASTY, THE SURGEON WAS ATTEMPTING TO SEAT THE POLYETHYLENE BEARING WITHIN THE HUMERAL TRAY USING MANUAL PRESSURE ON THE BACK TABLE. AFTER MULTIPLE ATTEMPTS, THE IMPLANTS ASSEMBLED. THE SURGEON NOTED THAT THE RING APPEARED TO BE BENT INITIALLY, AND AFTER ASSEMBLY, THE METAL RING WAS OBSERVED TO BE FRACTURED AT THE EDGE OF THE RING, RESULTING IN THE TRAY AND POLYETHYLENE BEARING COMING APART WITH LITTLE EFFORT. THE SURGEON USED A BACKUP TRAY AND THE ORIGINAL BEARING TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUES. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825677 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A PROCEDURE APPROXIMATELY 4 YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED ABOUT A MONTH AGO DUE TO PAIN, REACTIVE TISSUE, FLUID IN THE CAPSULE, AND TISSUE BETWEEN THE BASEPLATE AND GLENOSPHERE. THERE IS POSSIBLE METALLOSIS OR ALLERGY. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain

  MAUDE report 17643718 ↗
• InjuryJun 28, 2023Fracture; Fracture

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

  Patient problems: Failure of Implant; Joint Dislocation; Pain

  MAUDE report 17219154 ↗
• InjuryJun 6, 2023Material Erosion; Naturally Worn; Material Erosion; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER REVERSE TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY SEVEN (7) YEARS AND (B)(6) AGO, SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO METALOSIS OF THE IMPLANTS. THE PATIENT IS SCHEDULED FOR A SECOND REVISION SURGERY IN APPROXIMATELY THREE (3) WEEKS TO IMPLANT CUSTOM IMPLANTS AND COMPLETE THE REVISION.

  Patient problems: Erosion; Failure of Implant; Joint Dislocation; Metal Related Pathology; Osteolysis; Osteopenia/ Osteoporosis; Pain

  MAUDE report 17072920 ↗
• MalfunctionMay 9, 2023Positioning Failure; Positioning Failure

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16894997 ↗
• InjuryMar 28, 2023Adverse 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; Peripheral Nervous Injury

  MAUDE report 16629971 ↗
• InjuryMar 27, 2023Fracture; Fracture

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT REVERSE SHOULDER ARTHROPLASTY APPROXIMATELY FIVE YEARS AGO. WHILE PUSHING ON A TIRE, THE PATIENT FELT THE SHOULDER POP. THE PATIENT WAS REVISED WHERE THE HUMERAL BASEPLATE WAS BROKEN. DURING THE REVISION THE BASEPLATE WAS FOUND TO BE DISLOCATED POSTERIORLY AND NOTED TO HAVE SHEARED AT THE JUNCTION OF THE PEG AND PLATE, WITH THE PEG STILL ATTACHED WITHIN THE HUMERAL STEM. MEDICAL RECORDS INDICATE THE STEM WAS WELL FIXED TO THE HUMERUS. IN AN ATTEMPT TO REMOVE THE BROKEN PIECES FROM THE STEM, THE STEM DISLODGED FROM THE HUMERUS. THE STEM, TIBIAL TRAY, AND BEARING WERE ALL REVISED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 16619079 ↗
• MalfunctionMar 20, 2023Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573758 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A CONVERSION FROM A HEMIARTHROPLASTY TO A REVERSE SHOULDER ARTHROPLASTY APPROXIMATELY THREE (3) YEARS AND EIGHT (8) MONTHS AGO. SUBSEQUENTLY, ONE (1) YEAR AND SEVEN (7) MONTHS LATER, PATIENT REPORTS UNUSUAL PAIN FOLLOWING A FALL ONTO OUTSTRETCHED HANDS. THE PATIENT UNDERWENT A COURSE OF PHYSICAL THERAPY AND TAKES OTC MEDICATIONS AS NEEDED FOR PAIN. APPROXIMATELY TWO (2) MONTHS AGO, RADIOGRAPHIC IMAGING DISPLAYED STRESS SHIELDING IN LATERAL CORTEX AND THE PATIENT IS EXPERIENCING SOME DIFFICULTY PERFORMING DAILY ACTIVITIES. NO PLAN FOR REVISION HAS BEEN REPORTED AND THE PATIENT HAS REMAINED EXTREMELY SATISFIED THROUGHOUT THE STUDY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Erosion; Fall; Pain

  MAUDE report 16382709 ↗
• MalfunctionNov 30, 2022Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887800 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING SHOULDER PAIN, INSTABILITY, AND ROM ISSUES APPROXIMATELY SEVEN YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 15212152 ↗
• InjuryMar 2, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR AND 2 DAYS POST IMPLANTATION DUE TO A FOREIGN OBJECT IDENTIFIED ON POST OP RADIOGRAPHS. THE OBJECT WAS REMOVED AND ALL COMPONENTS WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 13653259 ↗
• InjuryMar 1, 2022Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; 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; Osteolysis

  MAUDE report 13634059 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080642, K113069, 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-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-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-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-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-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-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-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.