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 instrument is a surgical tool used to seat parts of a shoulder implant during surgery. Its 104 reports, all malfunction reports, mostly describe the instrument's impactor tip breaking or cracking during implant insertion. There were no deaths and no injuries, and 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
- 103
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 00887868470103), received between Dec 20, 2021 and Sep 16, 2026 — classified as 103 malfunctions.
The most frequently reported specific device problem is “Fracture” (100 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
- Fracture100
- Crack3
Patient problems
- No Clinical Signs, Symptoms or Conditions103
Recent adverse event reports
The 25 most recent of 103 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionJun 17, 2026Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE IMPACTOR FRACTURED INTO TWO PIECES WHILE IMPACTING THE GLENOSPHERE. 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 25533824 ↗MalfunctionJun 3, 2026Fracture
IT WAS REPORTED THAT THE GRAY METAL IMPACTOR TIP BROKE WHILE IMPACTING THE GLENOSPHERE TO THE BASEPLATE TAPER ADAPTER ON THE BACK TABLE. THERE WAS NO PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25374086 ↗MalfunctionMay 21, 2026Fracture
IT WAS REPORTED THAT THE DEVICE WAS FOUND WITH BROKEN AND DETERIORATED PIECES. THERE WERE NO KNOWN IMPACTS OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25243172 ↗MalfunctionMay 20, 2026Fracture
IT WAS REPORTED THAT THE IMPACTOR BROKE DURING IMPLANT INSERTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25234311 ↗MalfunctionMar 26, 2026Fracture
IT WAS REPORTED THAT AN IMPACTOR 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 24698354 ↗MalfunctionMar 3, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24496731 ↗MalfunctionFeb 13, 2026Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON WAS USING THE COMPREHENSIVE IMPACTOR TO ENGAGE THE MINI TAPER ADAPTER TO THE GLENOSPHERE IMPLANT. SUBSEQUENTLY, THE GREY TIP ON THE IMPACTOR SPLIT INTO TWO. 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 24332095 ↗MalfunctionJan 15, 2026Crack
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24086148 ↗MalfunctionDec 22, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862268 ↗MalfunctionDec 2, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693523 ↗MalfunctionDec 1, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23685804 ↗MalfunctionNov 17, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569199 ↗MalfunctionNov 14, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23559436 ↗MalfunctionNov 13, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23549947 ↗MalfunctionOct 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 23208490 ↗MalfunctionSep 5, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE E, THE IMPACTOR HEAD FRACTURED AFTER THE FIRST STRIKE. 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 22976823 ↗MalfunctionSep 4, 2025Fracture; Fracture
IT WAS REPORTED THE IMPACTOR TIP FRACTURED DURING THE CASE. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REPORTED, AND NO FOREIGN BODIES WERE REPORTED RETAINED 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 22974221 ↗MalfunctionSep 4, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22962121 ↗MalfunctionAug 14, 2025Fracture; Fracture
IT WAS REPORTED THAT THE GREY GLENOSHERE IMPACTOR FRACTURED WHILE IMPACTING THE GLENOSHERE. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22805604 ↗MalfunctionJul 17, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE IMPACTOR WAS BROKEN DURING A PROCEDURE. NO PATIENT HARM WAS REPORTED. 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 22529390 ↗MalfunctionJul 15, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22506713 ↗MalfunctionJun 20, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22296620 ↗MalfunctionMay 13, 2025Fracture; 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 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 22011955 ↗MalfunctionMay 13, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY THAT THE IMPACTOR FRACTURED. THERE WAS NO HARM, INJURY, SURGICAL/MEDICAL INTERVENTION TO PATIENT AND NO REPORT OF A DELAY. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22009186 ↗
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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