Comprehensive® Shoulder System 113042Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00880304212220), received between Dec 3, 2020 and Jun 5, 2026 — classified as 14 injuries.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION APPROXIMATELY THREE MONTHS POST-IMPLANTATION DUE TO SUBSCAPULARIS FAILURE ATTRIBUTED TO PATIENT NONCOMPLIANCE LEADING TO A COMPONENT DISLOCATION. DURING THE REVISION, THE SURGEON CHANGED THE HEAD TO A SMALLER SIZE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation; Periprosthetic fracture

  MAUDE report 25415199 ↗
• InjuryJun 13, 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 22202975 ↗
• InjuryMay 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY ON AN UNKNOWN DATE DUE TO AN UNKNOWN REASON USING A CUSTOM VRS IMPLANT. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Insufficient Information; Osteopenia/ Osteoporosis

  MAUDE report 22003640 ↗
• InjuryNov 25, 2024Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.

  Patient problems: Bone Fracture(s); Failure of Implant; Metal Related Pathology; Pain

  MAUDE report 20772513 ↗
• InjuryNov 4, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  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 20599110 ↗
• InjuryOct 5, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT IS BEING INDICATED FOR AN UPCOMING REVISION PROCEDURE DUE TO SUBLUXATION/DISLOCATION. DURING THE PATIENT'S APPOINTMENT LIGAMENT LAXITY AND VOLUNTARY INSTABILITY WERE NOTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bacterial Infection; Inadequate Osseointegration; Joint Dislocation; Joint Laxity; Medical device site infection; Pain

  MAUDE report 17875958 ↗
• 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 17861409 ↗
• 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 Impingement; Loss of Range of Motion; Pain

  MAUDE report 17818707 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BEGAN TO HAVE SEVERE SHOULDER PAIN, MODERATE DIFFICULTIES COMPLETING DAILY ACTIVITIES, LIMITED RANGE OF MOTION, AND MUSCLE WEAKNESS APPROXIMATELY TEN MONTHS POST OPERATION. THE PATIENT REPORTS SHARP POPPING PAIN IN THE ANTERIOR SHOULDER WITH A TWISTING MOTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion; Muscle Weakness/Atrophy; Muscle/Tendon Damage; Numbness; Pain

  MAUDE report 17653118 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY FOUR (4) YEARS AND ONE (1) MONTH POST-IMPLANTATION DUE TO ROTATOR CUFF FAILURE AND LOOSE GLENOID COMPONENT. SURGEON STATED THAT AT THE TIME OF THE PRIMARY IMPLANTATION, THE PATIENT HAD UNDIAGNOSED INFLAMMATORY ARTHROPATHY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Damage to Ligament(s); Failure of Implant; Inflammation

  MAUDE report 13624682 ↗
• InjuryNov 19, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843353 ↗
• InjurySep 1, 2021Material Erosion; Material Erosion

  UPON REASSESSMENT OF THE REPORTED EVENT, THIS DEVICE WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Metal Related Pathology

  MAUDE report 12408316 ↗
• InjuryMar 12, 2021Adverse 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

  MAUDE report 11472675 ↗
• InjuryDec 3, 2020Migration; Migration

  NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Tissue Damage

  MAUDE report 10938499 ↗

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