Comprehensive® Reverse Shoulder 115398Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304677104), received between Nov 3, 2020 and May 20, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2026Fracture

  IT WAS REPORTED THAT A 6.5 MM CENTRAL SCREW FRACTURED INTRA-OPERATIVELY DURING INSERTION. DURING INSERTION, THE SCREW WAS FIRST ADVANCED UNDER POWER AND THEN TURNED MANUALLY, AT WHICH POINT THE SCREW BEGAN TO EXHIBIT BREAKAGE. THE PORTION ATTACHED TO THE SCREW HEAD WAS SUBSEQUENTLY REMOVED BUT A PORTION WAS RETAINED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25233911 ↗
• MalfunctionMar 31, 2026Fracture

  IT WAS REPORTED THAT DURING AN INITIAL ARTHROPLASTY PROCEDURE, THE CENTRAL SCREW FRACTURED WITHIN THE PATIENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE FOREIGN BODY BUT WAS UNABLE TO REMOVE IT. THE PROPER SURGICAL TECHNIQUE WAS REPORTED TO HAVE BEEN USED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24740044 ↗
• InjuryNov 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS FURTHER REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 13 MONTHS POST IMPLANTATION DUE TO GLENOID LOOSENING AND PAIN IN THE SHOULDER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Pain

  MAUDE report 20709023 ↗
• InjuryAug 14, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant

  MAUDE report 19981244 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. ONLY THE STEINMANN PIN CONTAINS NICKEL, WHICH IS THE CONFIRMED METAL ALLERGY ALLEGATION. THIS PRODUCT IS CONFIRMED TO NOT CONTAIN NICKEL; THEREFORE, THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16410308 ↗
• InjuryAug 10, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT A TWO STAGE REVISION ARTHROPLASTY OF THE LEFT SHOULDER PROSTHESIS APPROXIMATELY SIXTEEN (16) MONTHS POST REVISION ARTHROPLASTY DUE TO INFECTION, WHICH CAUSED THE LOOSENING OF THE IMPLANT AND LED BONE LOSS OF THE GLENOID. DUE TO THIS, THE IMPLANT FRACTURED. THE PHYSICIAN FEELS THAT THE INFECTION STARTED AFTER THE INITIAL SURGERY AND THAT IT HAS REMAINED UNTIL THIS TWO STAGE REVISION WHEN THE INFECTION WAS TREATED.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Unspecified Infection

  MAUDE report 15206577 ↗
• InjuryJun 29, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT A TWO STAGE REVISION ARTHROPLASTY OF THE LEFT SHOULDER PROSTHESIS APPROXIMATELY 16 MONTHS POST REVISION ARTHROPLASTY DUE TO INFECTION, WHICH CAUSED LOOSENING OF THE SCREWS AND LED BONE LOSS OF THE GLENOID. THE PHYSICIAN FEELS THAT THE INFECTION STARTED AFTER THE INITIAL SURGERY AND THAT IT HAS REMAINED UNTIL THIS TWO STAGE REVISION WHEN THE INFECTION WAS TREATED. NO ADDITIONAL PATIENT IMPACT REPORTED.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Unspecified Infection

  MAUDE report 14858993 ↗
• InjuryMar 2, 2022Material Erosion; Loosening of Implant Not Related to Bone-Ingrowth; Material Erosion; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, IN AN UNKNOWN TIMEFRAME POST-IMPLANTATION, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING WITH PERIPROSTHETIC OSTEOLYSIS, WEAR OF THE POLY COMPONENT, AND METALLOSIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 13653516 ↗
• InjuryNov 3, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE PMI GROUP THE PATIENT UNDERWENT A SHOULDER PROCEDURE APPROXIMATELY FIVE (5) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY THREE (3) WEEKS POST-IMPLANTATION DUE TO GLENOSPHERE DISASSOCIATION CAUSED BY THE SURGEON NOT FIXATING THE CENTRAL SCREW COMPLETELY DOWN. A NEW CENTRAL SCREW WAS PUT IN AND POLY WAS EXCHANGED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10778936 ↗