Comprehensive® Reverse Shoulder 115395Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00880304677074), received between Apr 11, 2019 and Feb 23, 2026 — classified as 1 death, 20 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (8 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jan 15, 2021Terminated

   Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.

   Z-1131-2021 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT REVISION USING A CUSTOM IMPLANT APPROXIMATELY 1 YEAR AND 1 MONTH POST IMPLANTATION DUE TO THE PATIENT'S GLENOID BONE FRACTURING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME

  Patient problems: Bone Fracture(s)

  MAUDE report 24415331 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM A CLINICAL STUDY THAT A PATIENT HAD AN LEFT TOTAL SHOULDER. SUBSEQUENTLY, THE PATIENT HAS REPORTED AN INCREASE IN SHOULDER PAIN, AT TIMES SEVERE, WITH AN ONSET DATE OF APPROXIMATELY 6 YEARS POSTOP. IT IS UNKNOWN IF REVISION SURGERY IS RECOMMENDED OR PLANNED. NO INTRAOPERATIVE COMPLICATIONS. NO FURTHER INFORMATION REGARDING TREATMENT OR INTERVENTION HAS BEEN PROVIDED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 23610453 ↗
• InjuryAug 27, 2025Adverse 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 6 MONTHS POST IMPLANTATION DUE TO IMPLANT DISASSOCIATION AND MASSIVE GLENOID EROSION. THE PATIENT WAS CONVERTED TO A HEMIARTHROPLASTY AND WILL BE IMPLANTED WITH A CUSTOM BASEPLATE ON AN UNKNOWN DATE IN THE FUTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Erosion

  MAUDE report 22903777 ↗
• DeathJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY IN RECOVERY FOLLOWING A REVERSE TOTAL SHOULDER REPLACEMENT WITH THE COMPREHENSIVE SYSTEM. AS FAR AS THE SURGEON WAS CONCERNED, THE OPERATION WAS COMPLETED AS EXPECTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22530359 ↗
• InjuryJun 18, 2025Material Erosion; Fracture; Material Erosion; Fracture

  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.

  Patient problems: Aseptic loosening; Metal Related Pathology; Pain; Radiolucent Lines

  MAUDE report 22285127 ↗
• InjuryApr 30, 2025Loosening 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 21933863 ↗
• InjuryDec 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Inadequate Pain Relief; Osteopenia/ Osteoporosis

  MAUDE report 20831450 ↗
• InjurySep 24, 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: Bone Fracture(s)

  MAUDE report 20292124 ↗
• InjuryMay 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT SHOULDER REVISION DUE TO DISASSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19354121 ↗
• InjuryApr 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY ONE (1) YEAR AND TWO (2) MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS INDICATED FOR A REVISION WITH PMI PRODUCT DUE TO ALLEGED BASEPLATE LOOSENING. THE REPORTER ALSO NOTED AN APPARENT PROBLEM WITH THE PATIENT'S BONE QUALITY. A REVISION HAS NOT BEEN CONFIRMED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 19116230 ↗
• MalfunctionMar 25, 2024Material Deformation; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967838 ↗
• MalfunctionJun 22, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT APPROXIMATELY 10 YEARS POST IMPLANTATION OF A TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO DISASSOCIATION OF THE BASEPLATE. DURING THE PROCEDURE, IT WAS ALSO NOTED THAT THE CENTRAL SCREW HAD BACKED OUT. THE SURGEON THEN DRILLED FOR A NEW CENTRAL SCREW AND WAS UNABLE TO GET THE SCREW TO BE POSITIONED PROPERLY DUE TO ALLEGED BONEY INGROWTH INTO THE BASEPLATE. THE SURGEON DECIDED TO PROCEED WITHOUT PLACEMENT OF A CENTRAL SCREW, AS THE BASEPLATE WAS ALLEGEDLY WELL-FIXED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE AND NONE HAS BEEN PROVIDED.

  Patient problems: Extraskeletal ossification

  MAUDE report 17181744 ↗
• InjuryJun 1, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant

  MAUDE report 17037679 ↗
• InjuryMar 16, 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: Erosion; Fall; Pain

  MAUDE report 16552678 ↗
• InjuryFeb 14, 2023Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth; Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT HAD INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY TWO (2) YEARS AGO. THEN, ABOUT FIVE (5) MONTHS LATER THE PATIENT REPORTED PAIN. COMPUTERIZED TOMOGRAPHY (CT) AND RADIOGRAPHS REVEALED ACROMIAL STRESS FRACTURE HEALING, SUPERIOR TILT, SCAPULAR NOTCHING, LOOSENING OF THE BASEPLATE, AND FAILURE OF THE REVERSE BASEPLATE. TWO MONTHS LATER, AN ASPIRATION WAS CONDUCTED AND RULED OUT INFECTION. A 2-STAGE REVISION WAS PLANNED TO PLACE SPACERS TO OBTAIN PROPER IMAGING FOR IMPLANTS OF WORN GLENOID. SUBSEQUENTLY THE FIRST STAGE REVISION WAS DELAYED DUE TO PATIENT. CONSEQUENTLY, FOUR (4) MONTHS LATER THE 1ST STAGE REVISION WAS CONDUCTED, AND THE SURGEON NOTED THE STEM WAS WELL FIXED AND THE SURGEON OPTED TO KEEP THE STEM IMPLANTED. THEREFORE, THE SURGEON SWITCHED THE REVISION TO A HEMIARTHROPLASTY WITHOUT SPACERS. THE GLENOID WAS LOOSE AND EXCHANGED. THEN, ABOUT FIVE (5) MONTHS LATER THE 2ND STAGE REVISION OF HEMIARTHROPLASTY TO A REVERSE TOTAL SHOULDER ARTHROPLASTY WAS COMPLETED. NO OPERATIVE RECORDS PROVIDED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Bone Fracture(s); Erosion; Failure of Implant; Pain

  MAUDE report 16370957 ↗
• InjuryJan 25, 2023Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth; Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Bone Fracture(s); Erosion; Failure of Implant; Pain

  MAUDE report 16241908 ↗
• InjurySep 7, 2022Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE CENTRAL SCREW FRACTURING. THE SURGEON USED ONLY TWO SCREWS, ONE SCREW INFERIOR AND ONE SCREW SUPERIOR TO IMPLANT THE IMPLANT. THE PATIENT REPORTEDLY ROLLED OVER WHILE ASLEEP CAUSING THE FRACTURE OF THE SCREW.

  Patient problems: Failure of Implant

  MAUDE report 15372083 ↗
• InjuryMar 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT IS BEING CONSIDERING FOR A REVISION AT AN UNKNOWN DATE DUE TO TOTAL FAILURE OF THE GLENOID COMPONENTS (BROKEN SCREWS AND BASEPLATE PULLED OUT FROM GLENOID). ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 13758021 ↗
• InjuryMay 19, 2021Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848685 ↗
• MalfunctionFeb 9, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THE SURGEON WAS UNSATISFIED WITH THE WAY THE PLATE WAS IMPACTING, AND AFTER SOME ADJUSTING, DECIDED ON A DIFFERENT SCREW. THE ORIGINAL SCREW WAS DISCARDED AND NOT IMPLANTED. NO ISSUES OR PROBLEMS FOR THE SURGEON OR PATIENT WERE EXPERIENCED DUE TO THIS EVENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11302906 ↗
• InjuryAug 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY APPROXIMATELY NINE (9) MONTHS AGO. SUBSEQUENTLY THE PATIENT DISASSOCIATED DURING PT, AND WAS REVISED APPROXIMATELY THREE (3) MONTHS POST PRIMARY IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10385276 ↗
• InjuryJun 19, 2020Fracture; Fracture

  IT WAS REPORTED THAT PATIENT PRESENTED FOR 6 MONTH FOLLOW UP POST RIGHT SHOULDER HEMIARTHROPLASTY WHERE X-RAYS REVEALED A BROKEN CENTRAL SCREW WITH GLENOID LOOSENING AND MIGRATION. THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 6 DAYS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10174077 ↗
• InjuryApr 1, 2020Adverse 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; Swelling; Thrombus

  MAUDE report 9912563 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY EIGHT MONTHS POST INITIAL DUE TO INFECTION. A SPACER MOLD WAS TEMPORARILY IMPLANTED AND REMOVED AT A LATER DATE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 9311933 ↗
• MalfunctionApr 11, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT AS REPORTED THAT THE INNER PACKAGE WAS OPEN COMPROMISING THE STERILITY. NO ADVERSE CONSEQUENCES FOR THE PATIENT OR SURGICAL DELAY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 8503404 ↗