Comprehensive® Shoulder System 118001Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00880304217249), received between Nov 3, 2019 and Sep 29, 2026 — classified as 41 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 reports).

18 other recalls cover devices cleared under the same FDA submission (K060716, K080642, K193038); 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 41 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Detachment of Device or Device Component

  Patient problems: Joint Impingement

  MAUDE report 50933815 ↗
• InjuryMay 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AFTER THE INITIAL REVISION FOR INSTABILITY, THE GLENOSPHERE DISSOCIATED AND ANOTHER REVISION PROCEDURE WAS PERFORMED. INTRA-OPERATIVE ASSESSMENT REPORTEDLY DID NOT IDENTIFY AN IMPLANT DEFECT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231493 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SHOULDER HEMIARTHROPLASTY DUE TO HUMERAL NECK FRACTURE. THE PATIENT IS REQUESTING PRODUCT IDENTIFICATION TO SCHEDULE REVISION DUE TO PAIN AND LIMITED RANGE OF MOTION. PATIENT STATES ADDITIONAL RADIOLOGY REPORTS PROVIDE FINDINGS OF A COMPLETE TEAR OF THE TENDON AND SUSPICION OF LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Loss of Range of Motion; Muscle/Tendon Damage; Pain

  MAUDE report 25203777 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL IMPLANTATION APPROXIMATELY FOUR (4) YEARS AND SIX (6) MONTHS AGO. SUBSEQUENTLY, IT WAS NOTED POST-OPERATIVELY THAT THE TM MODULAR PEG OF THE GLENOID PENETRATED THE POLY LINER AND PROTRUDED. THE PATIENT UNDERWENT A REVISION APPROXIMATELY FOUR (4) YEARS AND FIVE (5) MONTHS POST-IMPLANTATION WHERE THE INITIAL PLAN WAS TO CONVERT FROM A TSA TO RTSA; HOWEVER, DUE TO METALLOSIS AND SEVERE BONE RESORPTION, IMPLANTING A GLENOID IMPLANT WAS UNABLE TO OCCUR. THEREFORE, BONE WAS HARVESTED FROM THE ILIUM AND USED FOR A BONE GRAFT AT THE SITE OF THE RESORPTION. IT IS NOTED THE PATIENT WAS VERY ACTIVE, IN WHICH THIS EVENT HAS CAUSED POST-OP MANAGEMENT DIFFICULT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Erosion; Metal Related Pathology

  MAUDE report 25184073 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL SHOULDER PROCEDURE AND WAS SUBSEQUENTLY REVISED AFTER A ROTATOR CUFF FAILURE DUE TO A FALL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Muscle/Tendon Damage

  MAUDE report 23468397 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY 5 MONTHS POST-IMPLANTATION THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21996746 ↗
• InjuryDec 31, 2024Device Dislodged or Dislocated; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A SHOULDER SYSTEM. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION AND LOOSENING OF THE GLENOSPHERE. 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: Aseptic loosening; Joint Dislocation

  MAUDE report 21047293 ↗
• InjuryNov 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY ON AND UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION DUE TO THE DISLOCATION OF THE HUMERAL HEAD AND GLENOID. WHILE THE SURGEON WAS EXPLANTING THE IMPLANTS IT WAS NOTED THAT THE ANTERIOR LIGAMENT WAS TORN AND WHILE REMOVING THE HUMERAL HEAD FROM THE PATIENT IT DISASSOCIATED FROM THE TAPER IMPLANT.

  Patient problems: Joint Dislocation

  MAUDE report 20598903 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20455782 ↗
• InjuryAug 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HEAD OF THE PROSTHESIS SEPARATED FROM THE STEM. THE PATIENT WAS TO BE RE-OPERATED IN THE SAME HOSPITAL WHERE THE FIRST PROCEDURE WAS PERFORMED, BUT HE DECIDED NOT TO. NO FURTHER INFORMATION IS KNOWN.

  Patient problems: Failure of Implant

  MAUDE report 20108194 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL RIGHT SHOULDER ARTHROPLASTY APPROXIMATELY 9 YEARS AGO. SUBSEQUENTLY ABOUT A MONTH AGO THE PATIENT REPORTED UNUSUAL PAIN AND A DECREASE IN RANGE OF MOTION WITH REFERRAL FOR CONSULTANT AND UNKNOWN TREATMENT. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Connective Tissue Disease; Loss of Range of Motion; Pain

  MAUDE report 18954017 ↗
• InjuryJan 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY SEVEN MONTHS POST-INITIAL IMPLANTATION DUE TO THE DISLOCATION OF THE PROSTHESIS. INTRAOPERATIVELY, THERE WAS LOOSENING OF THE CENTRAL SCREW AS WELL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 18605877 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT EXPERIENCED A FALL, LEADING TO DISLOCATION OF A LEFT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. THE SHOULDER WAS LEFT IN THE DISLOCATED POSITION FOR SEVERAL DAYS AND AFTER UNSUCCESSFUL ATTEMPTS OF A CLOSED REDUCTION, THE PATIENT UNDERWENT A CONVERSION TO A LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY A MONTH AGO. SUBSEQUENTLY, A DAY LATER, THE PATIENT DEVELOPED A DVT IN THE FOREARM THAT WAS SUCCESSFULLY MANAGED BY A CARDIOVASCULAR TEAM AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. NO FURTHER INFOMATION IS KNOWN AT THIS TIME.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18193996 ↗
• 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 18118674 ↗
• 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 18118667 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY TWO YEARS AGO. THE PATIENT UNDERWENT A TWO-STAGE REVISION SURGERY, THE FIRST STAGE A YEAR AND A HALF AFTER THE INITIAL SURGERY AND THE SECOND APPROXIMATELY FOUR MONTHS AGO DUE TO THE SCREWS FRACTURING. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR AN ADDITIONAL REVISION SURGERY DUE TO THE PATIENT BEING UNHAPPY WITH THE RESULTS OF HER PREVIOUS REVISION SURGERIES AND DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 17942168 ↗
• InjuryOct 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 17861408 ↗
• InjurySep 26, 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: Joint Dislocation; Joint Impingement; Loss of Range of Motion; Pain

  MAUDE report 17818705 ↗
• InjuryJan 31, 2023Unstable; Noise, Audible; Unstable; Noise, Audible

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

  Patient problems: Arthritis; Failure of Implant; Joint Laxity; Muscle/Tendon Damage; Pain; Subluxation

  MAUDE report 16270794 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS TO UNDERGO A REVISION SIX(6) YEARS POST IMPLANTATION DUE DISASSOCIATION AND PAIN. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain; Synovitis

  MAUDE report 15959398 ↗
• InjuryNov 30, 2022Adverse 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 2.5 YEARS POST IMPLANTATION DUE TO DISASSOCIATION OF THE GLENOID AND METAL POST. DURING THE REVISION, FOUND THE STEM WITH SIGNIFICANT METALLOSIS TYPE OF DEBRIS AROUND IT, RESORPTION NOTED AROUND THE NECK OF THE HUMERUS AND THE CALCAR, SYNOVITIS RESULTING IN A COMPLETE SYNOVECTOMY, A PIECE OF THE POLYETHYLENE BASEPLATE THAT FRACTURED OFF AND WAS LEFT ATTACHED TO THE INGROWTH POST, WEAR TO THE GLENOID, AND SIGNIFICANT GLENOID DAMAGE WITH POSTERIOR EROSION AND A B2 TYPE OF CONFIGURATION. ALL COMPONENTS WERE REMOVED WITHOUT COMPLICATION AND COMPETITOR PRODUCT WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Erosion; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 15887885 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) YEARS AGO. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY DUE TO EXCESSIVE GLENOID RETROVERSION. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

  Patient problems: Failure of Implant

  MAUDE report 15797821 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS FOUND TO HAVE WOUND DEHISCENCE 1 MONTH POST IMPLANTATION OF A LEFT TOTAL SHOULDER ARTHROPLASTY. THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS AND IS TO FOLLOW UP AGAIN IN CLINIC. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Wound Dehiscence

  MAUDE report 15527628 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAD REVISION SURGERY APPROXIMATELY ONE YEAR AND EIGHT MONTHS AFTER THE INITIAL SURGERY DUE TO PAIN, LOSS OF RANGE OF MOTION, AND LOOSENING OF THE IMPLANTS.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 15310376 ↗
• InjuryMay 5, 2022Adverse 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 7 MONTHS POSTIMPLANTATION DUE TO UNKNOWN REASONS. 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 14288596 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060716, K080642, K193038. One submission often covers many models, so check the product and lot details in each record.

• Z-1403-2025 · Mar 3, 2025 · Open, Classified
  Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
• 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-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-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-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-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-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-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-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

…and 3 more.