Comprehensive® Instrumentation 110028055Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
All models of COMPREHENSIVE INSTRUMENTATION (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00887868469978), received between Apr 20, 2022 and Aug 12, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Fracture” (15 reports).
3 other recalls cover devices cleared under the same FDA submission (K132239, 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
- Fracture15
Patient problems
- No Clinical Signs, Symptoms or Conditions15
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionNov 19, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23599166 ↗MalfunctionNov 17, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE INSTRUMENT TO IMPLANT THE IMPLANT, THE TIP OF THE INSTRUMENT FRACTURED. THERE WAS NO FOREIGN BODY OR HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569193 ↗MalfunctionApr 24, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE IMPACTOR WAS FRACTURED DURING A PROCEDURE. NO BROKEN PIECES FELL INTO THE PATIENT¿S SURGICAL AREA. 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 21903327 ↗MalfunctionFeb 12, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, THE IMPACTOR TIP FRACTURED DURING IMPACTION. 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 21368606 ↗MalfunctionJan 6, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPACTOR FRACTURED DURING SURGERY. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21080820 ↗MalfunctionJul 16, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19750802 ↗MalfunctionApr 26, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE 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 19190655 ↗MalfunctionDec 8, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A PRIMARY SURGERY THE IMPACTOR FRACTURED DURING IMPACTING OF GLENOSPHERE. NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18296485 ↗MalfunctionApr 3, 2023Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT FRACTURED ON THE BACK TABLE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED AND AN ALTERNATE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16663644 ↗MalfunctionNov 9, 2022Fracture; Fracture
IT WAS REPORTED THAT THE GREY TIP IMPACTOR BROKE DURING IMPACTION. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15762253 ↗MalfunctionOct 14, 2022Fracture; Fracture
IT WAS REPORTED THAT INSTRUMENT WAS RECEIVED FRACTURED. MULTIPLE REQUESTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15607396 ↗MalfunctionSep 19, 2022Fracture; Fracture
IT WAS REPORTED THAT WHILE USING THE INSTRUMENT THE TIP OF THE INSTRUMENT FRACTURED WHILE IMPACTING IMPLANT. NO FOREIGN BODY WAS RETAINED BY THE PATIENT. THERE WAS NO HARM TO THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15447165 ↗MalfunctionSep 7, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A COMPREHENSIVE SURGERY, WHEN THE PROSTHESIS WAS IMPACTED, THE PLASTIC TIP OF THE IMPACTOR FRACTURED. ANOTHER IMPACTOR WAS USED TO FINISH THE SURGERY. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15371974 ↗MalfunctionApr 20, 2022Fracture; Fracture
IT WAS REPORTED THAT AFTER THE INSTRUMENT WAS CLEANED IN THE WASH THAT THE TIP OF THE INSTRUMENT WAS CRACKED. IT WAS NOT NOTICED DURING THE SURGICAL PROCEDURE AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14163563 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K132239, K193373. One submission often covers many models, so check the product and lot details in each record.
- Z-1131-2021 · Jan 15, 2021 · TerminatedCentral Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
- 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 shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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