COMPREHENSIVE INSTRUMENTATION 110029132Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
All models of COMPREHENSIVE INSTRUMENTATION (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet Comprehensive shoulder surgery instrument has 118 adverse event reports, with 1 injury and no deaths. Nearly all describe the instrument's tip breaking or cracking during surgery. 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
- 116
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 00880304731516), received between Feb 6, 2020 and Sep 30, 2026 — classified as 1 injury, 115 malfunctions.
The most frequently reported specific device problem is “Fracture” (115 reports).
2 other recalls cover devices cleared under the same FDA submission (K193373); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Fracture115
- Detachment of Device or Device Component2
- Crack1
- Degraded1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions109
- No Consequences Or Impact To Patient6
- Insufficient Information2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 25 most recent of 116 reports, 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 21, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839693 ↗MalfunctionJul 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50093848 ↗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 ↗MalfunctionJun 2, 2026Fracture
IT WAS REPORTED THAT A METAL IMPACTOR TIP BROKE INTRA-OPERATIVELY DURING SECONDARY SEATING OF THE GLENOSPHERE. 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 25365541 ↗MalfunctionFeb 18, 2026Fracture
IT WAS REPORTED THAT AN IMPACTION PAD BROKE DURING A PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24375570 ↗MalfunctionJan 5, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23957831 ↗MalfunctionNov 24, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23638811 ↗MalfunctionNov 18, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE INSTRUMENT DURING SECONDARY IMPACTION, THE TIP FRACTURED. AN ALTERNATIVE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF A FOREIGN BODY OR HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23583266 ↗MalfunctionSep 3, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956463 ↗MalfunctionJun 30, 2025Crack; Crack
IT WAS REPORTED THAT AFTER A PROCEDURE WAS COMPLETED, THE TECH NOTICED THAT THE IMPACTOR WAS CRACKED. 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 22360204 ↗MalfunctionMay 13, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, THE IMPACTOR TIP FRACTURED DURING THE FINAL IMPACTION TO THE GLENOSPHERE. THE CORRECT SURGICAL TECHNIQUE WAS USED, AND THE IMPACTOR WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. THE CASE WAS COMPLETED WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22015061 ↗MalfunctionFeb 25, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21458865 ↗MalfunctionFeb 18, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE INSTRUMENT THE TIP FRACTURED FROM THE INSTRUMENT. THERE WAS NO REPORT OF FOREIGN BODY RETAINED OR HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21399366 ↗MalfunctionFeb 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPACTOR WAS FRACTURED WHILE IMPACTING THE GLENOSPHERE AND ANOTHER IMPACTOR WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21396695 ↗MalfunctionJan 29, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PLASTIC PART OF IMPACTOR FRACTURED. NO FURTHER INFORMATION IS KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21267363 ↗MalfunctionDec 2, 2024Fracture; Fracture
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20820905 ↗MalfunctionNov 27, 2024Fracture; Fracture
IT WAS REPORTED THAT THE IMPACTOR TIP FRACTURED WITHIN A SURGICAL CASE. THE CORRECT SURGICAL TECHNIQUE WAS USED, AND NO COMPLICATIONS, INJURIES, SURGICAL INTERVENTIONS, OR FOREIGN BODIES WERE REPORTED DUE TO THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20790469 ↗MalfunctionNov 25, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY THAT THE IMPACTOR FRACTURED. THERE WAS NO HARM OR INJURY TO PATIENT AND NO REPORTED DELAY. DUE DILIGENCE IS IN PROGRESS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20773329 ↗MalfunctionOct 7, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY FOR RIGHT SHOULDER ARTHROPLASTY THAT THE GLENOID IMPACTOR BROKE. THERE WAS NO HARM OR INJURY TO PATIENT AND NO REPORTED DELAY. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPACTOR. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20384353 ↗MalfunctionSep 27, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, THE IMPACTOR TIP FRACTURED DURING IMPACTION. THE CORRECT SURGICAL TECHNIQUE WAS USED. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. THE CASE WAS COMPLETED WITH THE DEVICE WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20322420 ↗MalfunctionMay 16, 2024Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS IMPACTING THE IMPLANT THE INSTRUMENT BROKE. ADDITIONAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19333185 ↗MalfunctionApr 24, 2024Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE INSTRUMENT TO IMPACT THE IMPLANT, THE TIP OF THE INSTRUMENT FRACTURED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19172395 ↗MalfunctionApr 11, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE APPROXIMATELY THREE (3) WEEKS AGO, THE GREY TIP OF THE IMPACTOR FRACTURED. 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 19092704 ↗MalfunctionApr 3, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE IMPACTOR BROKE WHILE IMPACTING THE GLENOSPHERE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19031643 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K193373. One submission often covers many models, so check the product and lot details in each record.
- Z-0619-2021 · Nov 25, 2020 · TerminatedComprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 1805
- Z-0093-2021 · Sep 2, 2020 · TerminatedBiomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for t
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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