ComprehensiveRecalls & reported problems across all models
Zimmer, Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Comprehensive model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 103
- Deaths reported
- 1
- Injuries reported
- 85
- Recalls
- 3
We found 18 models of Comprehensive by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 103 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2019 and Sep 28, 2026 — classified as 1 death, 85 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (41 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Comprehensive recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 20, 2026Open, Classified
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Z-2529-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 20, 2026Open, Classified
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Z-2528-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 20, 2026Open, Classified
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Z-2527-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Comprehensive problems
Device problems
- Detachment of Device or Device Component41
- Adverse Event Without Identified Device or Use Problem21
- Device Dislodged or Dislocated15
- Tear, Rip or Hole in Device Packaging7
- Fracture5
- Unstable5
- Malposition of Device4
- Device Contaminated During Manufacture or Shipping3
Patient problems
- Failure of Implant30
- Joint Dislocation22
- No Clinical Signs, Symptoms or Conditions19
- Pain14
- Insufficient Information13
- Bone Fracture(s)6
- Joint Laxity4
- Unspecified Infection4
Comprehensive models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Comprehensive 110040240Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 recall2 reports
- Comprehensive 110040241Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 recall0 reports
- Comprehensive 110040242Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 recall0 reports
- Comprehensive® 110031399prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death36 reports
- Comprehensive® 110031405PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED20 reports
- Comprehensive® 110031402prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented9 reports
- Comprehensive® 110031407prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented9 reports
- Comprehensive® 110031400PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED6 reports
- Comprehensive® 110031403PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED5 reports
- Comprehensive® 110031404PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Comprehensive® 110031408shoulder prosthesis, reverse configuration3 reports
- Comprehensive® 110031401shoulder prosthesis, reverse configuration2 reports
- Comprehensive® 110031406prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Comprehensive® 110031411prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- Comprehensive® 110031414prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- Comprehensive® 110031431PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Comprehensive® 110031441PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Comprehensive 110040435Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 report
Recent Comprehensive adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Tear, Rip or Hole in Device Packaging
It was reported the box the implant was in was sealed, but the plastic bag it was in had a large tear in it. The event was identified during surgery, but the surgeon decided to implant it anyway after soaking it in beta-dine. It was reported that no further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916727 ↗InjurySep 14, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50764163 ↗MalfunctionSep 14, 2026Tear, Rip or Hole in Device Packaging
Patient problems: Insufficient Information
MAUDE report 50754585 ↗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 ↗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 ↗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 ↗InjuryJul 31, 2026Detachment of Device or Device Component
It was reported that the patient underwent an initial implantation on an unknown date. Subsequently, the patient was revised approximately nineteen (19) months ago due to disassociation of the poly bearing from the tray. Attempts have been made and no further information has been provided.
Patient problems: Crepitus; Insufficient Information
MAUDE report 50096877 ↗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 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 ↗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 ↗InjuryJun 8, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY 3 MONTHS POST-IMPLANTATION DUE TO LOOSENING OF THE INLAY DESPITE ENGAGEMENT OF THE LOCKING MECHANISM. THE LOOSENING WAS NOTED DURING THE POSTOPERATIVE PERIOD. DURING THE REVISION PROCEDURE, INTRA-OPERATIVE ASSESSMENT CONFIRMED THE INLAY WAS LOOSE; THE SURGEON REVISED THE LOOSE INLAY AND RE-IMPLANTED THE INLAY COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening
MAUDE report 25427758 ↗InjuryMay 10, 2026Detachment of Device or Device Component
UPDATED 10 MAY 2026: IT WAS REPORTED THAT THE GLENOSPHERE AND TAPER ADAPTER SEPARATED FROM THE BASEPLATE FOLLOWING AN INITIAL SHOULDER ARTHROPLASTY PROCEDURE, REQUIRING A REVISION APPROXIMATELY ONE (1) WEEK LATER. DURING THE REVISION PROCEDURE, THE CENTRAL SCREW WAS OBSERVED TO BE DOWN, AND IT WAS NOTED THAT SOFT TISSUE MAY HAVE PREVENTED THE GLENOSPHERE FROM PROPERLY ENGAGING THE TAPER, POSSIBLY DUE TO A FALL. THE REVISION PROCEDURE WAS SUCCESSFUL, AND NO ADDITIONAL HARM, SYMPTOMS, OR IMPACTS WERE REPORTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133784 ↗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 ↗InjuryFeb 4, 2026Mechanical Jam
IT WAS REPORTED THAT DURING SHOULDER SURGERY THE ANTERIOR PORTION OF THE GLENOID FRACTURED WHEN THE REAMER BLADE INTERACTED WITH A DISPOSABLE OFF-AXIS REAMER GUIDE. DURING INTRA-OPERATIVE REAMING, THE BLADE DUG INTO THE PLASTIC OF THE GUIDE, WHICH TORQUED THE GLENOID AND RESULTED IN AN ANTERIOR GLENOID FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s)
MAUDE report 24258069 ↗
Other Zimmer, Inc. products
- PERSONA364 models · 2,000 reports · 3 recalls
- Persona The Personalized Knee77 models · 1,396 reports
- PERSONA Vivacit-E285 models · 1,152 reports
- NexGen198 models · 842 reports · 4 recalls
- Affixus18 models · 1 reports · 17 recalls
- PERSONA Natural Tibia25 models · 417 reports · 2 recalls
- NexGen Legacy119 models · 319 reports · 3 recalls
- Alliance32 models · 275 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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