COMPREHENSIVE INSTRUMENTATIONRecalls & reported problems across all models
Biomet Orthopedics, LLC · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 413
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 18 models of COMPREHENSIVE INSTRUMENTATION by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 413 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2019 and Sep 30, 2026 — classified as 6 injuries, 407 malfunctions.
The most frequently reported specific device problem is “Fracture” (374 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. 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
Most reported COMPREHENSIVE INSTRUMENTATION problems
Device problems
- Fracture374
- Naturally Worn22
- Crack6
- Dull, Blunt5
- Degraded3
- Break2
- Detachment of Device or Device Component2
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions399
- No Consequences Or Impact To Patient7
- Foreign Body In Patient3
- Insufficient Information3
- No Known Impact Or Consequence To Patient2
- No Patient Involvement2
- No Code Available1
COMPREHENSIVE INSTRUMENTATION models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- COMPREHENSIVE INSTRUMENTATION 110029132PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED116 reports
- Comprehensive® Instrumentation 110029132PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED103 reports
- COMPREHENSIVE INSTRUMENTATION 110028879shoulder prosthesis, reverse configuration71 reports
- COMPREHENSIVE INSTRUMENTATION 110028055PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED35 reports
- Comprehensive® Instrumentation 110028879PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED28 reports
- Comprehensive® Instrumentation 110029136PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED16 reports
- COMPREHENSIVE INSTRUMENTATION 110029136PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED15 reports
- Comprehensive® Instrumentation 110028055shoulder prosthesis, reverse configuration15 reports
- COMPREHENSIVE INSTRUMENTATION 405889BIT, DRILL3 reports
- COMPREHENSIVE INSTRUMENTATION 405901ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- COMPREHENSIVE INSTRUMENTATION 405806shoulder prosthesis, reverse configuration2 reports
- COMPREHENSIVE INSTRUMENTATION 405885BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- COMPREHENSIVE INSTRUMENTATION 405906PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- COMPREHENSIVE INSTRUMENTATION 405808PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- COMPREHENSIVE INSTRUMENTATION 110028878PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- COMPREHENSIVE® INSTRUMENTATION 110025762shoulder prosthesis, reverse configuration1 report
- Comprehensive® Instrumentation 405889BIT, DRILL1 report
- Comprehensive® Instrumentation 405901Orthopedic manual surgical instrument1 report
Recent COMPREHENSIVE INSTRUMENTATION adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fracture
It was reported that an impactor tip broke. Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947502 ↗MalfunctionSep 28, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923846 ↗MalfunctionSep 21, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839693 ↗MalfunctionSep 16, 2026Fracture
It was reported the metal impactor tip fractured. No complications, injuries, or surgical interventions were reported, and no foreign bodies were retained due to this malfunction. The correct surgical technique was used, and an alternate device was used to complete the procedure successfully. It was reported that no further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788923 ↗MalfunctionSep 16, 2026Fracture
It was reported that during a procedure, the shoehorn was being used to position the implants when it snapped at the tip. The surgery was completed using the same device. No 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 50785971 ↗MalfunctionSep 15, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776287 ↗MalfunctionSep 15, 2026Naturally Worn
It was reported that the surgeon complained that baseplate reamer wasn't sharp enough to hollow out bone from Glenoid. It was reported that no further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773346 ↗MalfunctionSep 9, 2026Fracture
It was reported that while loading the glenosphere, the plastic tip of the instrument was discovered to be broken. Another set was opened with no delay or issues. There were no consequences or impact to the patient. Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691833 ↗MalfunctionAug 27, 2026Fracture
It was reported that the glenosphere inserter pad broke. Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476951 ↗MalfunctionAug 17, 2026Fracture
It was reported that the tip of a glenosphere impactor fractured during impaction. The event occurred intra-operatively while the surgeon was impacting the glenosphere, and the procedure was completed using a secondary instrument. There were no consequences or impact to the patient. Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50275249 ↗MalfunctionAug 12, 2026Fracture
No further event information available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50221290 ↗MalfunctionJul 31, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50096885 ↗MalfunctionJul 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50093848 ↗MalfunctionJun 29, 2026Fracture
IT WAS REPORTED THAT THE TIP OF AN INSERTER BROKE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25651133 ↗MalfunctionJun 23, 2026Fracture
IT WAS REPORTED THAT DURING IMPACTION OF THE GLENOSPHERE, THE GREY TIP BROKE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25595834 ↗
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
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 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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