Comprehensive® Shoulder System 113032Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00880304212206), received between May 17, 2021 and Mar 3, 2025 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K040610, K060716, 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 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: Insufficient Information

  MAUDE report 21504629 ↗
• InjuryJun 26, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT REVISION PROCEDURE APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO INSTABILITY AND DISLOCATION COMPLICATED BY LESSER TUBEROSITY REPAIR FAILURE. THE INITIAL STEM REMAINED INTACT, AND ALL OTHER COMPONENTS WERE REVISED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Joint Dislocation; Muscle/Tendon Damage

  MAUDE report 19618071 ↗
• InjuryMay 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT GLENOID WAS REVISED TWO MONTHS POST-INITIAL PROCEDURE DUE TO PAIN, LIMITED RANGE OF MOTION, BONE FRACTURE, DROP ARM POSITIVE, AND SUBLUXATION. PRIOR TO THE REVISION, THE SURGEON ATTEMPTED TO MANIPULATE THE SHOULDER WITH NO SUCCESS. THE SURGEON ALSO NOTED THAT THE PATIENT DID NOT HAVE ANY HISTORY OF TRAUMA. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Bone Fracture(s); Loss of Range of Motion; Pain; Scar Tissue; Subluxation

  MAUDE report 19368261 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY APPROXIMATELY FIVE (5) YEARS AGO. SUBSEQUENTLY, THE PATIENT HAD A REVISION ON THREE (3) MONTHS AGO DUE TO A SUPRASPINATUS TEAR IN THE ROTATOR CUFF. NO OTHER PATIENT CONSEQUENCES HAVE BEEN REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 18347265 ↗
• InjuryOct 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 17985233 ↗
• InjuryJun 7, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT AN INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED APPROXIMATELY 3 YEARS AGO. SUBSEQUENTLY, THE PATIENT REPORTED TO HER SURGEON THAT SHE HAD BEEN DOING FINE UNTIL SHE REACHED DOWN TO GRAB SOMETHING AND FELT A PAIN IN HER LEFT SHOULDER. FOLLOW UP RADIOLOGY CONFIRMED FRACTURE OF THE CENTRAL SCREW WITH SUBSEQUENT LOOSENING AND OSTEOLYSIS FROM DEBRIS GENERATION. THE PATIENT REPORTS SHE HAS SINCE HAD PAIN, DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, AND LIMITED RANGE OF MOTION. THE PATIENT WAS REVISED TO A REVERSE TOTAL SHOULDER APPROXIMATELY A YEAR AND A HALF AGO DUE TO GLENOID IMPLANT FRACTURE. DURING THE REVISION, EVIDENCE OF METALLOSIS AND WEAR WERE FOUND AS WELL AS CYSTIC DEFECTS AND SIGNIFICANT SCAR TISSUE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH UNKNOWN PRODUCT EXCEPT FOR SPECIFYING IMPLANTATION OF A BIOMET BASE PLATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME AND THE STUDY IS NOW COMPLETE.

  Patient problems: Cyst(s); Failure of Implant; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Subluxation

  MAUDE report 17081281 ↗
• InjuryJan 10, 2023Fracture; Detachment of Device or Device Component; Naturally Worn; Fracture; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION OF BASEPLATE AND POLY. FURTHER, THE SURGEON ALSO STATED THAT THE POST WAS SHEARED OFF. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 16129990 ↗
• 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 15959386 ↗
• 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 15527625 ↗
• InjurySep 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY THREE YEARS POST IMPLANTATION DUE TO ROTATOR CUFF FAILURE. ALL IMPLANTS WERE REMOVED AND REPLACED WITH A REVERSE SHOULDER SYSTEM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 15462050 ↗
• MalfunctionAug 29, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  T 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: Joint Dislocation; Loss of Range of Motion; Pain

  MAUDE report 15310372 ↗
• 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 14288708 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT AN INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED. AT THE 5-YEAR VISIT, THE PATIENT REPORTED MODERATE PAIN, INSTABILITY, IMPINGEMENT, AND LOSS OF RANGE OF MOTION. GLENOID COMPONENT MIGRATION WAS NOTED ON THE X-RAY. THE PATIENT HAS BEEN REFERRED FOR AN ORTHOPEDIC CONSULT BUT HAS NOT YET HAD ANY INTERVENTION. THE OUTCOME IS PENDING.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 11835670 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040610, K060716, 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