Comprehensive® Instrumentation 110029136Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00887868470110), received between Nov 13, 2023 and Sep 28, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (8 reports).

5 other recalls cover devices cleared under the same FDA submission (K120121, 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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923846 ↗
• MalfunctionJan 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A REAMER WAS RETURNED WITH A DIFFERENT COMPLAINT WITH NO INFORMATION AVAILABLE. INVESTIGATION OF THE REAMER DETERMINED IT WAS WORN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24045408 ↗
• MalfunctionDec 1, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THE MINI BASEPLATE REAMER TIP WAS DULL. 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 23680762 ↗
• MalfunctionNov 24, 2025Naturally Worn; Naturally Worn

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632967 ↗
• MalfunctionOct 6, 2025Naturally Worn; Naturally Worn

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23223381 ↗
• MalfunctionSep 11, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THE CENTER POST REAMER WAS DULL. THE CASE WAS COMPLETED WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031852 ↗
• MalfunctionAug 27, 2025Naturally Worn; Naturally Worn

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903407 ↗
• MalfunctionJun 11, 2025Degraded; Naturally Worn; Degraded; Naturally Worn

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185929 ↗
• MalfunctionApr 14, 2025Material Fragmentation; Material Fragmentation

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21833816 ↗
• MalfunctionMar 18, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT PRIOR TO SURGERY ON THAT THE MINI BASEPLATE REAMER WAS BENT; IT WAS NOTICED THAT WHEN THE REAMER WAS CONNECTED TO POWER AND STARTED TO SPIN THAT IS SEEMED TO WOBBLE AND THE SURGEON FELT LIKE IT MUST BE BENT AND ASKED FOR A REPLACEMENT. THERE WAS NO HARM, INJURY, MEDICAL/SURGICAL INTERVENTION OR DELAY REPORTED. DUE DILIGENCE COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630925 ↗
• MalfunctionMar 6, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING SURGERY, IT WAS OBSERVED THAT THE REAMER WAS DULL. 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 21534833 ↗
• MalfunctionApr 29, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE INSTRUMENT, THE INSTRUMENT WAS VERY DULL AND HARDLY CUT THROUGH BONE. A SECOND INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19205663 ↗
• MalfunctionMar 22, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE REAMER WAS BENT. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959869 ↗
• MalfunctionDec 4, 2023Naturally Worn; Naturally Worn

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255255 ↗
• MalfunctionNov 20, 2023Naturally Worn; Naturally Worn

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169907 ↗
• MalfunctionNov 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE BASEPLATE REAMER FRACTURED DURING A SETUP ASSEMBLY. THIS MALFUNCTION WAS NOT ASSOCIATED WITH A SURGICAL PROCEDURE, AND THERE WAS NO PATIENT IMPACT OR INVOLVEMENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18119223 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120121, K193373. One submission often covers many models, so check the product and lot details in each record.

• Z-0619-2021 · Nov 25, 2020 · Terminated
  Comprehensive 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 · Terminated
  Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for t
• Z-1615-2020 · Feb 25, 2020 · Terminated
  Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain a
• Z-0972-2019 · Dec 21, 2018 · Terminated
  Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use i
• Z-1208-2015 · Jan 7, 2015 · Terminated
  Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400