Comprehensive® 110031405Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00887868231377), received between Sep 14, 2021 and Sep 10, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 reports).

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Detachment of Device or Device Component; Noise, Audible

  It was reported that a disassociation/dislocation occurred approximately two months after implantation of a right reverse total shoulder arthroplasty. The patient reported a clicking sensation and a feeling that something was "off" prior to presentation. The patient underwent revision, during which the polyethylene bearing was exchanged. No patient injury, sequelae, or outcome was reported beyond the disassociation/dislocation and the revision procedure. The surgical technique used during the initial procedure was indicated to have been followed. Attempts have been made, and no further information has been provided.

  Patient problems: Crepitus; Joint Dislocation

  MAUDE report 50706042 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient underwent a revision due to infection. Attempts have been made and no further information has been provided.

  Patient problems: Unspecified Infection

  MAUDE report 50519276 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a revision reverse total shoulder arthroplasty was performed on the right shoulder due to instability. The construct had been in place for approximately four (4) weeks. The humeral tray and the humeral bearing were removed and replaced. The humeral stem was not removed. No additional consequences to the patient were reported. Attempts have been made and no further information has been provided.

  Patient problems: Joint Laxity

  MAUDE report 50127024 ↗
• InjuryJun 23, 2026Malposition of Device

  IT WAS REPORTED THE PATIENT EXPERIENCED IMPINGEMENT AND PAIN ATTRIBUTED TO IMPLANT MALPOSITION AND SUBSEQUENTLY UNDERWENT REVISION APPROXIMATELY 17 MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Impingement; Pain

  MAUDE report 25594642 ↗
• InjuryJun 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT EXPERIENCED EARLY DISLOCATIONS FOLLOWING AN INITIAL SHOULDER ARTHROPLASTY AND SUBSEQUENTLY UNDERWENT A REVISION APPROXIMATELY 12 MONTHS POST-IMPLANTATION DUE TO CONTINUED INSTABILITY AND DISLOCATION. APPROXIMATELY 1 MONTH POST-IMPLANTATION AND AGAIN APPROXIMATELY 2 MONTHS POST-IMPLANTATION, THE SHOULDER DISLOCATED AND WAS MANAGED WITH CLOSED REDUCTIONS. INSTABILITY PERSISTED. AT REVISION EXPOSURE, THE HUMERAL BEARING WAS NOTED TO HAVE COME OFF THE HUMERAL TRAY. THE HUMERAL TRAY/BEARING AND THE GLENOSPHERE WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 25503909 ↗
• InjuryAug 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A PATIENT HAD A SHOULDER REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE TWO DAYS POST IMPLANTATION DUE TO COMPONENT DISASSOCIATION. NO ADDITIONAL COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REPORTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22823170 ↗
• InjuryJun 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY FOUR (4) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE BEARING AND HUMERAL TRAY TO DISASSOCIATE, CAUSING THE GLENOSPHERE TO DISLOCATE FROM THE BEARING. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 22366887 ↗
• 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: Metal Related Pathology; Pain; Radiolucent Lines

  MAUDE report 22342447 ↗
• InjuryFeb 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A PRIMARY LEFT REVERSE TSA. THE PATIENT WAS PRESENTED WITH DYSFUNCTION LEFT SHOULDER AND PAIN AND WAS REVISED THREE MONTHS POST INITIAL PROCEDURE DUE TO DISASSOCIATION OF THE POLY FROM THE HUMERAL BASEPLATE. SURGEON NOTED UPON ENTRY FOUND SCAR TISSUE, BLOODY EFFUSION AND PARTIALLY TORN SUBSCAPULARIS TENDON.

  Patient problems: Adhesion(s); Failure of Implant; Joint Laxity; Joint effusion; Muscle/Tendon Damage; Pain

  MAUDE report 21375004 ↗
• InjuryOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Failure of Implant

  MAUDE report 20438563 ↗
• InjuryJul 22, 2024Insufficient 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 19798274 ↗
• InjuryJun 4, 2024Adverse 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

  MAUDE report 19459860 ↗
• InjuryDec 14, 2023Adverse 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 INFECTION APPROXIMATELY SEVEN WEEKS POST INITIAL PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 18327672 ↗
• InjuryDec 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. UPON EXAMINATION AND CURRENT XRAY, IT WAS NOTED THAT THE REVERSE LINER HAD DISASSOCIATED FROM ITS TRAY AND WAS THE CAUSE THE INSTABILITY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18320665 ↗
• InjuryMay 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Failure of Implant

  MAUDE report 16984616 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY TWO (2) AND A HALF MONTHS LATER DUE TO POST OPERATIVE DRAINAGE, A HEMATOMA, AND BLEEDING IN THE SHOULDER JOINT. THERE WERE NO SIGNS OF AN INFECTION AS THE PATIENT'S WHITE BLOOD CELL COUNT WAS NOT FOUND INTRAOPERATIVE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16460227 ↗
• InjuryFeb 20, 2023Noise, Audible; Noise, Audible

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

  Patient problems: Discomfort

  MAUDE report 16406037 ↗
• MalfunctionSep 7, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A SURGERY BEFORE IMPLANTATION IT WAS FOUND THAT THE HUMERAL BEARING POLY WAS SHIFTING ROUGHLY 1-3MM IN EITHER DIRECTION. THE BEARING WAS THEN DISASSOCIATE FROM THE HUMERAL TRAY WITH THE SURGEON'S HANDS, AND THE HUMERAL BEARING BROKE OFF. THE SURGRON THEN PROCEEDED TO TRY ANOTHER POLY. IT DID THE EXACT SAME THING, EXCEPT THE TABS DID NOT BREAK ON THE SECOND POLY. WE THEN TRIED A THIRD 40 +3 POLY WHICH DID THE EXACT SOME THING AS THE PREVIOUS TWO, EXCEPT THE DOCTOR LEFT THE BEARING IN THE PATIENT AND FINISHED THE CASE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15373303 ↗
• InjuryApr 27, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY SIX (6) MONTHS POST-IMPLANTATION DUE TO DISLOCATION CAUSED BY DISASSOCIATION OF THE POLY BEARING AND TRAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Dislocation; Muscle Weakness/Atrophy

  MAUDE report 14218722 ↗
• InjurySep 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 12468193 ↗