Comprehensive® 110031399Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
Quick summary
This Zimmer Comprehensive shoulder implant is used to replace a damaged shoulder joint. The 36 reports mostly describe the implant loosening or coming apart, dislocating, or sitting in the wrong position after surgery, leading to pain and repeat revision operations; 1 report describes a death and 33 describe injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 36
- Deaths reported
- 1
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00887868231315), received between Jun 4, 2020 and Sep 14, 2026 — classified as 1 death, 33 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem12
- Detachment of Device or Device Component12
- Device Dislodged or Dislocated6
- Malposition of Device3
- Loosening of Implant Not Related to Bone-Ingrowth2
- Mechanical Jam1
- Misassembled During Installation1
- Positioning Failure1
Patient problems
- Failure of Implant14
- Pain9
- Insufficient Information5
- Joint Dislocation5
- No Clinical Signs, Symptoms or Conditions3
- Bone Fracture(s)2
- Erosion2
- Unspecified Infection2
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50764163 ↗InjurySep 1, 2026Device Dislodged or Dislocated
It was reported that a revision reverse total shoulder arthroplasty was performed on the left shoulder due to dislocation. The revision was performed seven weeks after implantation. The patient was unaware when or for how long the shoulder was dislocated. The humeral tray and bearing were explanted, and the bearing was upsized to provide additional stability. It was reported that no further information is available.
Patient problems: Joint Dislocation
MAUDE report 50538905 ↗InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS BEING CONSIDERED FOR A REVISION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25588366 ↗InjuryFeb 23, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT A REVISION PROCEDURE FOR A LEFT REVERSE TOTAL SHOULDER WAS PERFORMED DUE TO A DISLOCATION, WHICH OCCURRED APPROXIMATELY SIX (6) WEEKS FOLLOWING THE INITIAL PROCEDURE. DURING THE REVISION, THE HUMERAL TRAY AND BEARING WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT HARM WAS REPORTED. THE OUTCOME OF THE PROCEDURE WAS NOT PROVIDED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 24414052 ↗InjuryNov 13, 2025Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY APPROXIMATELY ONE (1) YEAR AND THREE (3) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY A MONTH AND A HALF AGO DUE TO IMPINGEMENT AND PAIN. DURING THE REVISION, NOTED NOTCH IMPINGEMENT. THE GLENOSPHERE, HUMERAL TRAY, AND BEARING WERE EXCHANGED WITHOUT COMPLICATIONS, THE BASEPLATE, FOUR SCREWS, AND HUMERAL STEM REMAINED IMPLANTED.
Patient problems: Joint Impingement; Pain
MAUDE report 23544139 ↗DeathJul 17, 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 22530863 ↗InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY ELEVEN (11) MONTHS AGO. SUBSEQUENTLY, THERE HAS BEEN AN ALLEGED UNKNOWN COMPLICATION WITH NO KNOWN INTERVENTION TO DATE. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 22370957 ↗InjuryMay 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21960123 ↗InjuryMar 31, 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 A RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY PERFORMED. THE PATIENT DID VERY WELL THROUGHOUT THE STUDY UNTIL REPORTING SEVERE PAIN AND INSTABILITY WITH ACTIVITIES AT THE 5 YEAR FOLLOW UP. THERE WAS NO SPECIFIC ISSUES FOUND WITH THE IMPLANT NOR DID THE PATIENT HAVE ANY TRAUMA. THERE IS NO PLANNED REVISION SURGERY. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Pain
MAUDE report 21731624 ↗InjuryJan 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED ONE MONTH POST IMPLANTATION DUE TO DISASSOCIATION BETWEEN THE POLY AND THE HUMERAL TRAY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21159302 ↗InjuryJan 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT, ON AN UNKNOWN DATE, BEGAN TO EXPERIENCE PAIN AND A CRUNCHING SOUND AFTER LAYING DOWN AND ROLLING OVER. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY FOUR (4) MONTHS AGO DUE TO THE IMPLANTS DISASSOCIATING. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: Failure of Implant; Pain
MAUDE report 21111922 ↗InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT SHOULDER SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISION DUE TO INFECTION. THE INFECTION WAS TREATED WITH WASH OUT AND REPLACEMENT OF HUMERAL TRAY, BEARING, AND THE GLENOSPHERE. THERE WAS HARM OR INJURY TO PATIENT AS THE PATIENT HAD TO UNDERGO ADDITIONAL SURGICAL/MEDICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 20784864 ↗InjuryNov 18, 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 20706995 ↗InjuryOct 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: Joint Dislocation
MAUDE report 20345793 ↗InjurySep 12, 2024Unstable; Unstable
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 20202215 ↗InjurySep 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT WAS REVISED SIX MONTHS POST-INITIAL IMPLANTATION DUE TO THE DISASSOCIATION OF THE HUMERAL BEARING FROM THE HUMERAL TRAY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 20135951 ↗InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL COMPREHENSIVE REVERSE SHOULDER ARTHROPLASTY APPROXIMATELY THREE (3) YEARS AND FIVE (5) AND A HALF MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY A MONTH AGO DUE TO PAIN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Pain
MAUDE report 19498541 ↗InjuryJun 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECOND REVISION DUE TO DISLOCATION, ONE WEEK POST-INITIAL IMPLANTATION. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: Joint Dislocation
MAUDE report 19448586 ↗InjuryJan 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A REVERSE ARTHROPLASTY REVISION PROCEDURE WAS NEEDED DUE TO POLY LOOSENING IN THE JOINT APPROXIMATELY ONE (1) YEAR AND EIGHT (8) MONTHS AFTER INITIAL IMPLANTATION. NO OTHER INJURIES WERE REPORTED DUE TO THIS DISASSOCIATION, AND MEDICAL RECORDS ARE UNAVAILABLE FOR REVIEW. THE REVISION SURGERY WAS SUCCESSFUL WITHOUT ANY COMPLICATIONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 18425757 ↗InjuryOct 23, 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: Metal Related Pathology; Osteopenia/ Osteoporosis; Synovitis
MAUDE report 17985503 ↗InjurySep 25, 2023Malposition of Device; Malposition of Device
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Fungal Infection; Loss of Range of Motion; Pain
MAUDE report 17809401 ↗InjuryAug 24, 2023Detachment 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; No Clinical Signs, Symptoms or Conditions
MAUDE report 17611206 ↗InjuryApr 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY TWELVE DAYS POST IMPLANTATION DUE TO THE GLENOSPHERE LOOSENING FROM THE BASEPLATE. DURING THE PROCEDURE, IT WAS NOTED THAT THE POLY HAD DISASSOCIATED FROM THE HUMERAL TRAY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16798094 ↗InjuryFeb 21, 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: Hypersensitivity/Allergic reaction
MAUDE report 16410377 ↗InjuryFeb 2, 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 16282862 ↗
Other prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices
- Comprehensive Reverse Shoulder 115310Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death99 reports
- INHANCE 5120-00-110Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented75 reports
- Comprehensive® Reverse Shoulder XL-115364Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall7 reports
- Comprehensive® Reverse Shoulder XL-115366Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall4 reports
- Comprehensive® Reverse Shoulder 180550Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 deaths43 reports
- Comprehensive® Reverse Shoulder 180551Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- DJO SURGICAL 521-07-246Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® Reverse Shoulder 115396Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented35 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.