Comprehensive Reverse ShoulderRecalls & reported problems across all models
Biomet Orthopedics, LLC · 57 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 895
- Deaths reported
- 7
- Injuries reported
- 819
- Recalls
- 3
We found 57 models of Comprehensive Reverse Shoulder by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 895 adverse event reports in the FDA's MAUDE database, received between Apr 10, 2019 and Sep 30, 2026 — classified as 7 deaths, 819 injuries, 69 malfunctions.
The most frequently reported specific device problem is “Fracture” (161 reports).
3 FDA recall records name at least one of these models by its device 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. 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 Reverse Shoulder 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.
- 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 ↗
- Sep 2, 2020Terminated
Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters
Z-0093-2021 · Root cause: Packaging process control · Recall details · FDA record ↗
- Apr 17, 2020Terminated
Potential presence of elevated endotoxin levels that exceed the specification limit
Z-2144-2020 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported Comprehensive Reverse Shoulder problems
Device problems
- Adverse Event Without Identified Device or Use Problem240
- Fracture161
- Detachment of Device or Device Component147
- Loosening of Implant Not Related to Bone-Ingrowth141
- Device Dislodged or Dislocated115
- Unstable26
- Material Erosion24
- Insufficient Device Problem Information22
Patient problems
- Failure of Implant250
- Pain236
- Joint Dislocation149
- Insufficient Information98
- No Clinical Signs, Symptoms or Conditions77
- Erosion55
- Foreign Body In Patient53
- Bone Fracture(s)51
Comprehensive Reverse Shoulder models
57 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Comprehensive Reverse Shoulder 010000589PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- Comprehensive Reverse Shoulder 115310prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death99 reports
- Comprehensive® Reverse Shoulder 115395PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall1 death25 reports
- Comprehensive® Reverse Shoulder XL-115364prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall7 reports
- Comprehensive® Reverse Shoulder XL-115366prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall4 reports
- Comprehensive® Reverse Shoulder 180552PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 death51 reports
- Comprehensive® Reverse Shoulder 180553PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 death47 reports
- Comprehensive® Reverse Shoulder 180550prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 deaths43 reports
- Comprehensive Reverse Shoulder 115370PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED42 reports
- Comprehensive® Reverse Shoulder 180551prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® Reverse Shoulder 115396prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented35 reports
- Comprehensive® Reverse Shoulder 405800PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED31 reports
- COMPREHENSIVE® REVERSE SHOULDER 110032410prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death29 reports
- Comprehensive® Reverse Shoulder 180554PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED28 reports
- Comprehensive® Reverse Shoulder XL-115363prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented27 reports
- Comprehensive Reverse Shoulder 115313shoulder prosthesis, reverse configuration19 reports
- COMPREHENSIVE® REVERSE SHOULDER 110032420shoulder prosthesis, reverse configuration19 reports
- Comprehensive® Reverse Shoulder 115397prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented16 reports
- COMPREHENSIVE® REVERSE SHOULDER 110032430PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED14 reports
- Comprehensive Reverse Shoulder 115330shoulder prosthesis, reverse configuration13 reports
- Comprehensive® Reverse Shoulder 180555PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED13 reports
- Comprehensive® Reverse Shoulder 115340prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented11 reports
- Comprehensive Reverse Shoulder EP-115393PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED10 reports
- Comprehensive® Reverse Shoulder 115394prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented10 reports
- Comprehensive® Reverse Shoulder 115398PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED9 reports
- Comprehensive® Reverse Shoulder 180560prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented8 reports
- Comprehensive® Reverse Shoulder 115399PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED7 reports
- Comprehensive® Reverse Shoulder 115400prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented7 reports
- Comprehensive® Reverse Shoulder 180556prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented7 reports
- Comprehensive Reverse Shoulder 115375PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED6 reports
- Comprehensive® Reverse Shoulder 180559PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED6 reports
- Comprehensive® Reverse Shoulder 180561PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED6 reports
- Comprehensive® Reverse Shoulder 110040210PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED6 reports
- Comprehensive® Reverse Shoulder XL-115365prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented5 reports
- Comprehensive Reverse Shoulder 115378PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED5 reports
- Comprehensive Reverse Shoulder 115320PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Comprehensive Reverse Shoulder EP-115394PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Comprehensive Reverse Shoulder 115316PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Comprehensive® Reverse Shoulder XL-115367PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Comprehensive Reverse Shoulder EP-115395prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented3 reports
- Comprehensive® Reverse Shoulder 180557PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Comprehensive Reverse Shoulder TI-115310PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Comprehensive® Reverse Shoulder 115345prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Comprehensive Reverse Shoulder 115326PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Comprehensive® Reverse Shoulder XL-115368prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Comprehensive Reverse Shoulder EP-115396prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Comprehensive® Reverse Shoulder 180558prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Comprehensive® Reverse Shoulder 180562prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Comprehensive Reverse Shoulder TI-115326prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 reports
- Comprehensive® Reverse Shoulder 110040600PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Comprehensive Reverse Shoulder EP-115397prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- Comprehensive Reverse Shoulder 115331PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- COMPREHENSIVE REVERSE SHOULDER 115393prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- Comprehensive Reverse Shoulder TI-115313PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Comprehensive Reverse Shoulder TI-115320prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- COMPREHENSIVE® REVERSE SHOULDER 110040420prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
- Comprehensive® Reverse Shoulder 110040430PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
Recent Comprehensive Reverse Shoulder adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 50948320 ↗MalfunctionSep 29, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934095 ↗InjurySep 26, 2026Detachment of Device or Device Component
Patient problems: Pain
MAUDE report 50906502 ↗InjurySep 25, 2026Detachment of Device or Device Component
Patient problems: Pain
MAUDE report 50904422 ↗InjurySep 25, 2026Detachment of Device or Device Component
Patient problems: Pain
MAUDE report 50904276 ↗InjurySep 25, 2026Detachment of Device or Device Component
Patient problems: Pain
MAUDE report 50904230 ↗InjurySep 24, 2026Fracture
Patient problems: Foreign Body In Patient
MAUDE report 50884764 ↗InjurySep 24, 2026Device Dislodged or Dislocated
It was reported the patient underwent a reverse shoulder procedure. Subsequently, the patient had a revision procedure due to glenosphere dislocation approximately one month after surgery. Attempts have been made, and no further information has been provided.
Patient problems: Joint Dislocation
MAUDE report 50884332 ↗InjurySep 23, 2026Device Dislodged or Dislocated
It was reported that the patient underwent an initial implantation approximately one (1) month ago with the Identity RSA system. During the implantation, there was a noted instability during the procedure, the surgeon confirmed that it had not dislocated and concluded the surgery. Subsequently, the patient repeatedly dislocated after the surgery and a revision was performed approximately one (1) week post-implantation. Attempts have been made and no further information has been provided.
Patient problems: Joint Dislocation
MAUDE report 50872937 ↗InjurySep 23, 2026Detachment of Device or Device Component
It was reported the patient had a reverse shoulder system implanted. Approximately, 4 months post-operation, the patient reported increasing pain over the last 6 weeks to the surgeon. X-rays confirmed the broken screws and baseplate and taper adapted disassociation. Future revision surgery plan and date unknown. It was reported that no further information is available.
Patient problems: Pain
MAUDE report 50868970 ↗MalfunctionSep 21, 2026Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840739 ↗MalfunctionSep 21, 2026Difficult to Insert
It was reported that during a procedure, the mini taper was unable to be engaged into the 40mm glenosphere. It was noted that the taper sat proud event after impacting. The surgeon reverted to using a 36mm glenosphere instead and used a new taper with it successfully. There was a 15 minute delay to the case but no other patient consequences were reported as a result of the event. Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838805 ↗InjurySep 15, 2026Detachment of Device or Device Component
It was reported that following an initial reverse total shoulder arthroplasty, radiography performed after the procedure showed that the glenosphere had become dislodged/detached. The incision was reopened, and reinsertion of the glenosphere was attempted. The taper did not fit, and the central screw was retightened. The procedure was completed with a replacement taper adapter and a replacement glenosphere. Attempts have been made, and no further information has been provided.
Patient problems: Insufficient Information
MAUDE report 50769828 ↗InjurySep 15, 2026Detachment of Device or Device Component
It was reported that following an initial reverse total shoulder arthroplasty, radiography performed after the procedure showed that the glenosphere had become dislodged/detached. The incision was reopened, and reinsertion of the glenosphere was attempted. The taper did not fit, and the central screw was retightened. The procedure was completed with a replacement taper adapter and a replacement glenosphere. Attempts have been made, and no further information has been provided.
Patient problems: Insufficient Information
MAUDE report 50769824 ↗InjurySep 10, 2026Device Dislodged or Dislocated; 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 50706912 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 recalls
- Comprehensive Shoulder System68 models · 191 reports · 11 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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