Comprehensive® Reverse Shoulder 405800Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
Quick summary
This Biomet Comprehensive Reverse Shoulder implant is used to replace the shoulder joint. Most of the 27 reports describe small threaded pins used during surgery breaking off, sometimes staying in the patient's shoulder, along with a few packaging issues. There are 20 injuries and no deaths. 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
- 31
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00887868504563), received between Feb 21, 2023 and Sep 24, 2026 — classified as 25 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Fracture” (27 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture27
- Adverse Event Without Identified Device or Use Problem2
- Delivered as Unsterile Product1
- Difficult to Open or Remove Packaging Material1
- Packaging Problem1
Patient problems
- Foreign Body In Patient24
- No Clinical Signs, Symptoms or Conditions6
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Fracture
Patient problems: Foreign Body In Patient
MAUDE report 50884764 ↗InjurySep 2, 2026Fracture
It was reported that a threaded steinman pin broke off in the patient when the surgeon attempted to remove it. Attempts have been made and no further information has been provided.
Patient problems: Foreign Body In Patient
MAUDE report 50567315 ↗InjurySep 1, 2026Fracture
It was reported that during a procedure, the 3.2 Steinmann pin had fractured inside of the patient's bone. The surgeon attempted to remove the broken piece, but was unable to do so. Instead, the broken piece was retained. It was noted that this was a case of severe bone sclerosis in the patient, and it is believed that the pin fractured due to uneven force applied during insertion. Attempts have been made and no further information has been provided.
Patient problems: Foreign Body In Patient
MAUDE report 50547094 ↗InjuryAug 31, 2026Fracture
It was reported that during a left reverse total shoulder arthroplasty, a threaded Steinmann pin fractured off in the patient. Surgical technique was reported as used, with no deviation from the described surgical technique. Patient conditions/anatomy were reported as not contributing to the event. No medical or surgical intervention, no surgical delay, and no surgical complication were reported in connection with the event aside from the malfunction. It was reported that no further information is available.
Patient problems: Foreign Body In Patient
MAUDE report 50515074 ↗InjuryAug 23, 2026Fracture
It was reported that a Steinmann tip broke off into a patient's glenoid during a right reverse shoulder arthroplasty. A surgical intervention was not attempted to retrieve the fractured tip. The correct surgical technique was used, and no complications have been noted as a result of this malfunction. Attempts have been made, and no further information has been provided.
Patient problems: Foreign Body In Patient
MAUDE report 50393114 ↗InjuryAug 21, 2026Fracture
It was reported that a Steinmann pin broke off inside the glenoid during reaming for the post in an intra-operative shoulder procedure. Attempts have been made and no further information has been provided.
Patient problems: Foreign Body In Patient
MAUDE report 50380191 ↗InjuryJul 2, 2026Fracture
IT WAS REPORTED THAT A THREADED 3.2 PIN BROKE OFF IN THE PATIENT'S GLENOID DURING PLACEMENT AND WAS RETAINED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 25693052 ↗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 25243167 ↗InjuryMay 12, 2026Fracture
IT WAS REPORTED THAT THE TIP OF A STEINMANN PIN BROKE OFF IN THE GLENOI AND WAS RETAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 25149718 ↗MalfunctionMar 12, 2026Fracture
IT WAS REPORTED THAT THE TIP OF A STEINMANN PIN BROKE OFF. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583058 ↗InjuryMar 11, 2026Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, A DISPOSABLE PIN BROKE OFF INSIDE THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 24570896 ↗MalfunctionJan 12, 2026Fracture
IT WAS REPORTED THAT THE TIP OF A STEINMANN PIN BROKE OFF INTRA-OPERATIVELY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24032051 ↗MalfunctionJan 6, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 23975477 ↗InjuryDec 30, 2025Fracture; Fracture
IT WAS REPORTED THAT A STEINMANN PIN BROKE DURING A REVERSE SHOULDER PROCEDURE AND THE TIP WAS RETAINED BY THE PATIENT, WHICH WAS CONFIRMED IN AN X RAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 23928060 ↗InjuryDec 9, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 23761509 ↗InjuryDec 9, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 23758353 ↗InjuryDec 3, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A SURGERY, THE THREADED TIP OF THE STEINMANN PIN BROKE OFF DURING SURGERY. SUBSEQUENTLY, THE SURGEON OPTED TO LEAVE THE BROKEN TIP IN THE BONE. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT WAS REPORTED AT THE TIME OF THIS SUBMISSION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 23706568 ↗InjuryNov 18, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 23582534 ↗InjuryNov 6, 2025Fracture; Fracture
IT WAS REPORTED THAT A THREADED STEINMANN PIN FRACTURED WITH THE THREADED PORTION REMAINING IN THE PATIENT¿S GLENOID, REQUIRING THE USE OF A BROKEN SCREW REMOVAL SET AND TREPHINING OF ADDITIONAL BONE FOR EXTRACTION. INTRA-OPERATIVELY, THE RETAINED FRAGMENT WAS REMOVED USING THE BROKEN SCREW REMOVAL SET, AND ADDITIONAL BONE WAS TREPHINED TO FACILITATE REMOVAL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23491348 ↗InjurySep 18, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS INSERTING THE THREADED TIP GUIDE THE THREADS AT THE END FRACTURED OFF IN THE PATIENT. THE PIECE THAT FRACTURED OFF WAS RETAINED BY THE PATIENT. THERE WAS NO REPORT OF A PLANNED REVISION TO REMOVE THE PIECE THAT WAS RETAINED BY THE PATIENT AT THIS TIME. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 23088660 ↗InjuryAug 16, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 22823165 ↗InjuryAug 15, 2025Fracture; Fracture
IT WAS REPORTED THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY. THE TIP OF THE THREADED PIN FRACTURED OFF INSIDE THE PATIENT DURING GLENOID PREPARATION. IT WAS REPORTED THE SURGEON DECIDED TO COMPLETE THE PROCEDURE WITH THE FRACTURED PART WITHIN THE GLENOID OF THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 22815456 ↗InjuryJun 5, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE PIN BROKE OFF IN THE PATIENT¿S GLENOID AND WAS RETAINED DURING A PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 22149128 ↗InjuryMar 25, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 21690491 ↗InjuryFeb 25, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE INSTRUMENT THE TIP OF THE INSTRUMENT FRACTURED. AN ATTEMPT WAS MADE TO REMOVE THE TIP OF THE INSTRUMENT, BUT THE SURGEON WAS UNABLE TO REMOVE IT, AND THE PATIENT RETAINED THE PIECE OF THE INSTRUMENT. THERE IS NO REVISION SURGERY SCHEDULED TO EXPLANT THE FOREIGN BODY.
Patient problems: Foreign Body In Patient
MAUDE report 21457976 ↗
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 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.