COMPREHENSIVE SHOULDER 110005273Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304568105), received between Sep 1, 2021 and Feb 19, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K130390); 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
- Device Dislodged or Dislocated2
- Material Erosion1
Patient problems
- Loss of Range of Motion1
- Metal Related Pathology1
- Muscle Weakness/Atrophy1
- Pain1
- Subluxation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2026Device Dislodged or Dislocated
IT WAS REPORTED THROUGH A JOURNAL ARTICLE THAT ONE PATIENT WAS REVISED APPROXIMATELY 3.5 YEARS POSTOPERATIVELY TO A REVERSE SHOULDER ARTHROPLASTY DUE TO RECURRENT POSTERIOR SUBLUXATION, PAIN, AND DECREASED RANGE OF MOTION AND STRENGTH. DURING THE REVISION PROCEDURE, THE CONVERTIBLE BASEPLATE WAS RETAINED AND CONVERTED, AND THE BONE GRAFT FROM THE INDEX SURGERY DEMONSTRATED COMPLETE INTEGRATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Subluxation
MAUDE report 24390170 ↗InjurySep 1, 2021Material Erosion; Device Dislodged or Dislocated; Material Erosion; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Metal Related Pathology
MAUDE report 12408313 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K130390. 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
Other prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices
- Comprehensive Reverse Shoulder 115310Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death99 reports
- INHANCE 5120-00-110Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented75 reports
- Comprehensive® Reverse Shoulder XL-115364Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall7 reports
- Comprehensive® Reverse Shoulder XL-115366Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall4 reports
- Comprehensive® Reverse Shoulder 180550Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 deaths43 reports
- Comprehensive® Reverse Shoulder 180551Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- DJO SURGICAL 521-07-246Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® 110031399Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death36 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.