Comprehensive® Reverse Shoulder 180550Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00880304677135), received between Nov 26, 2019 and Feb 23, 2026 — classified as 2 deaths, 40 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (13 reports).

19 other recalls cover devices cleared under the same FDA submission (K080642, K130390, K132239); 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 43 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT REVISION USING A CUSTOM IMPLANT APPROXIMATELY 1 YEAR AND 1 MONTH POST IMPLANTATION DUE TO THE PATIENT'S GLENOID BONE FRACTURING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME

  Patient problems: Bone Fracture(s)

  MAUDE report 24415374 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT REVISION USING A CUSTOM IMPLANT APPROXIMATELY 1 YEAR AND 1 MONTH POST IMPLANTATION DUE TO THE PATIENT'S GLENOID BONE FRACTURING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME

  Patient problems: Bone Fracture(s)

  MAUDE report 24415332 ↗
• 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 23610473 ↗
• 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 23610469 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 6 MONTHS POST IMPLANTATION DUE TO IMPLANT DISASSOCIATION AND MASSIVE GLENOID EROSION. THE PATIENT WAS CONVERTED TO A HEMIARTHROPLASTY AND WILL BE IMPLANTED WITH A CUSTOM BASEPLATE ON AN UNKNOWN DATE IN THE FUTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Erosion

  MAUDE report 22903774 ↗
• DeathJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY IN RECOVERY FOLLOWING A REVERSE TOTAL SHOULDER REPLACEMENT WITH THE COMPREHENSIVE SYSTEM. AS FAR AS THE SURGEON WAS CONCERNED, THE OPERATION WAS COMPLETED AS EXPECTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22530379 ↗
• DeathJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY IN RECOVERY FOLLOWING A REVERSE TOTAL SHOULDER REPLACEMENT WITH THE COMPREHENSIVE SYSTEM. AS FAR AS THE SURGEON WAS CONCERNED, THE OPERATION WAS COMPLETED AS EXPECTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22530377 ↗
• InjuryJun 26, 2025Material Erosion; Material Erosion

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL ANATOMICAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE WITH UNKNOWN PRODUCTS. APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS AGO, THE PATIENT WAS REVISED TO A COMPREHENSIVE REVERSE TOTAL SHOULDER ARTHROPLASTY DUE TO GLENOID LOOSENING AND FAILED ROTATOR CUFF. SUBSEQUENTLY, THE PATIENT HAD FALLEN APPROXIMATELY ONE (1) YEAR AND FOUR (4) MONTHS POST-IMPLANTATION AND THEN BEGAN TO HAVE PAIN. RADIOGRAPHIC IMAGING DISPLAYED MALALIGNMENT OF THE GLENOSPHERE, FRACTURED SCREW, LUCENCY AROUND THE INFERIOR LOCKING SCREW, RADIO-DENSE BODIES SUPERIOR IN THE JOINT, AND LIKELY BONY FRAGMENTS INFERIORLY. APPROXIMATELY ONE (1) MONTH AGO, THE PATIENT UNDERWENT A REVISION WHERE A LITTLE BIT OF METALLOSIS OF THE SOFT TISSUE AROUND THE JOINT CAPSULE WAS ENCOUNTERED AND THE CENTRAL SCREW WAS FRACTURED. CANCELLOUS ALLOGRAFT WAS IMPLANTED AND THE PATIENT WAS CONVERTED TO A HEMIARTHROPLASTY WITH PLANS FOR A POSSIBLE REVISION IN THE FUTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Metal Related Pathology; Pain; Radiolucent Lines

  MAUDE report 22342444 ↗
• InjuryJun 26, 2025Material Erosion; Material Erosion

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL ANATOMICAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE WITH UNKNOWN PRODUCTS. APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS AGO, THE PATIENT WAS REVISED TO A COMPREHENSIVE REVERSE TOTAL SHOULDER ARTHROPLASTY DUE TO GLENOID LOOSENING AND FAILED ROTATOR CUFF. SUBSEQUENTLY, THE PATIENT HAD FALLEN APPROXIMATELY ONE (1) YEAR AND FOUR (4) MONTHS POST-IMPLANTATION AND THEN BEGAN TO HAVE PAIN. RADIOGRAPHIC IMAGING DISPLAYED MALALIGNMENT OF THE GLENOSPHERE, FRACTURED SCREW, LUCENCY AROUND THE INFERIOR LOCKING SCREW, RADIO-DENSE BODIES SUPERIOR IN THE JOINT, AND LIKELY BONY FRAGMENTS INFERIORLY. APPROXIMATELY ONE (1) MONTH AGO, THE PATIENT UNDERWENT A REVISION WHERE A LITTLE BIT OF METALLOSIS OF THE SOFT TISSUE AROUND THE JOINT CAPSULE WAS ENCOUNTERED AND THE CENTRAL SCREW WAS FRACTURED. CANCELLOUS ALLOGRAFT WAS IMPLANTED AND THE PATIENT WAS CONVERTED TO A HEMIARTHROPLASTY WITH PLANS FOR A POSSIBLE REVISION IN THE FUTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Metal Related Pathology; Pain; Radiolucent Lines

  MAUDE report 22342443 ↗
• InjuryMay 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS CONSIDERED FOR A PMI PRODUCT AND REVISED DUE TO LOOSENING AND INSTABILITY OF THE IMPLANT. DURING THE REVISION, IT WAS NOTED THAT THE CENTRAL SCREW WAS FRACTURED. ALL COMPONENTS WERE REMOVED AND REPLACED; HOWEVER, A PIECE OF THE FRACTURED CENTRAL SCREW COULD NOT BE REMOVED AS IT WAS RETAINED IN THE GLENOID.

  Patient problems: Aseptic loosening

  MAUDE report 22101937 ↗
• InjuryMar 31, 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 A RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY PERFORMED APPROXIMATELY 5.5 YEARS AGO. THE PATIENT DID VERY WELL THROUGHOUT THE STUDY UNTIL REPORTING SEVERE PAIN AND INSTABILITY WITH ACTIVITIES AT THE 5 YEAR FOLLOW UP. NO TREATMENT OR INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 21734201 ↗
• InjuryMar 31, 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 A RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY PERFORMED APPROXIMATELY 5.5 YEARS AGO. THE PATIENT DID VERY WELL THROUGHOUT THE STUDY UNTIL REPORTING SEVERE PAIN AND INSTABILITY WITH ACTIVITIES AT THE 5 YEAR FOLLOW UP. NO TREATMENT OR INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 21734195 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS GETTING DRESSED AND FELT A POPPING SENSATION WHICH LEAD TO THE REVISION PROCEDURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 21504804 ↗
• InjuryFeb 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A LOOSENING OF THE DEVICE. THERE WAS HARM OR INJURY TO PATIENT AS THE PATIENT HAD TO UNDERGO ADDITIONAL SURGICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 21369889 ↗
• InjuryJan 7, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SHOULDER ARTHROPLASTY APPROXIMATELY ONE MONTH AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED 8 DAYS LATER DUE TO INSTABILITY AND LOOSENING. PATIENT HAD NEW STEM AND TAPER PUT IN. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 21095603 ↗
• InjuryJan 7, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SHOULDER ARTHROPLASTY APPROXIMATELY ONE MONTH AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED 8 DAYS LATER DUE TO INSTABILITY AND LOOSENING. PATIENT HAD NEW STEM AND TAPER PUT IN. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 21095594 ↗
• InjuryDec 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis

  MAUDE report 20831452 ↗
• InjuryDec 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis

  MAUDE report 20831432 ↗
• InjuryNov 1, 2024Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION. IT WAS ALSO REPORTED THAT AN UNKNOWN AMOUNT OF SCREWS WERE LOOSE FROM THE BASE PLATE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20587301 ↗
• InjuryNov 1, 2024Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  IT WAS REPORTED THAT THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION. IT WAS ALSO REPORTED THAT AN UNKNOWN AMOUNT OF SCREWS WERE LOOSE FROM THE BASE PLATE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20587294 ↗
• InjuryNov 1, 2024Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION. IT WAS ALSO REPORTED THAT AN UNKNOWN NUMBER OF SCREWS WERE LOOSE FROM THE BASE PLATE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20587283 ↗
• InjuryNov 1, 2024Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  IT WAS REPORTED THAT THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION. IT WAS ALSO REPORTED THAT AN UNKNOWN AMOUNT OF SCREWS WERE LOOSE FROM THE BASE PLATE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20587277 ↗
• MalfunctionOct 17, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING SURGERY THAT THE ANCHOR WOULD NOT DEPLOY. THERE WAS NO HARM OR INJURY TO PATIENT. A DELAY OF APPROXIMATELY 15 MINUTES WAS REPORTED WHILE ANOTHER DEVICE WAS RETRIEVED. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20474239 ↗
• InjurySep 27, 2024Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED BASEPLATE LOOSENING FROM THE GLENOID FOLLOWING AN INITIAL ARTHROSCOPY PROCEDURE. THE SURGEON INDICATED THE PATIENT'S ANATOMY, WITH VERY LITTLE BONE IN THE GLENOID, LIKELY CAUSED THE FAILURE. IMAGING CONFIRMED THIS LOOSENING APPROXIMATELY FIFTEEN (15) MONTHS LATER. ADDITIONALLY, ONE (1) OF THE PERIPHERAL SCREWS WAS FOUND TO BE FRACTURED DURING RADIOGRAPH EVALUATION. A FUTURE REVISION IS PLANNED ON AN UNKNOWN DATE. NO OTHER INTERVENTIONS OR HARMS HAVE BEEN REPORTED DUE TO THIS EVENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20321584 ↗
• InjuryMay 21, 2024Fracture; Fracture

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

  Patient problems: Bacterial Infection; Failure of Implant; Pain

  MAUDE report 19358803 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080642, K130390, K132239. One submission often covers many models, so check the product and lot details in each record.

• Z-1131-2021 · Jan 15, 2021 · Terminated
  Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
• 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-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-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-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-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-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-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-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 4 more.