Hybrid Glenoid 113954Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Hybrid Glenoid (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00880304462489), received between Nov 11, 2019 and Nov 4, 2025 — classified as 13 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).
1 FDA recall record name this device's identifier.
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 18, 2026.
Reports received per month
Recalls naming this device
- Apr 17, 2020Class IITerminated
Potential presence of elevated endotoxin levels that exceed the specification limit
Z-2144-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Device Dislodged or Dislocated3
- Loosening of Implant Not Related to Bone-Ingrowth3
- Insufficient Device Problem Information1
- Migration1
- Naturally Worn1
- Unstable1
Patient problems
- Failure of Implant4
- Pain4
- Joint Dislocation3
- Inflammation2
- Insufficient Information2
- Loss of Range of Motion2
- Bacterial Infection1
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL SHOULDER PROCEDURE AND WAS SUBSEQUENTLY REVISED AFTER A ROTATOR CUFF FAILURE DUE TO A FALL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information; Muscle/Tendon Damage
MAUDE report 23468391 ↗InjuryOct 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: Joint Dislocation
MAUDE report 20474182 ↗InjuryOct 5, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT IS BEING INDICATED FOR AN UPCOMING REVISION PROCEDURE DUE TO SUBLUXATION/DISLOCATION. DURING THE PATIENT'S APPOINTMENT LIGAMENT LAXITY AND VOLUNTARY INSTABILITY WERE NOTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Bacterial Infection; Inadequate Osseointegration; Joint Dislocation; Joint Laxity; Medical device site infection; Pain
MAUDE report 17876078 ↗InjuryOct 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) AND A HALF YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY FIVE (5) YEARS AGO FOR AN UNKNOWN REASON. THE PATIENT WAS REVISED FROM AND ANATOMIC SHOULDER TO A REVERSE SHOULDER.
Patient problems: Insufficient Information
MAUDE report 17861417 ↗InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Impingement; Loss of Range of Motion; Pain
MAUDE report 17818718 ↗InjuryJun 27, 2023Naturally Worn; Naturally Worn
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17210739 ↗InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A STUDY PATIENT UNDERWENT AN ANATOMIC SHOULDER ARTHROPLASTY. IMMEDIATELY POSTOPERATIVE, THE PATIENT WAS NOTED TO HAVE RADIAL NERVE PALSY AS DIAGNOSED BY DROP HAND. THE PATIENT UNDERWENT EMG AND RADIOLOGIC DIAGNOSTICS. THE PATIENT STARTED USING A DROP HAND SPLINT/ BRACE AND PHYSIOTHERAPY WAS STARTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: Peripheral Nervous Injury
MAUDE report 16326239 ↗InjuryDec 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A TEAR OF THE ROTATOR CUFF. FURTHER, THE PATIENT HAD LOOSENING OF THE GLENOID COMPONENT AND DISLOCATION OF THE POLYETHYLENE FROM THE POST IMPLANT.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 15914637 ↗InjuryDec 27, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY FOUR (4) YEARS AND ONE (1) MONTH POST-IMPLANTATION DUE TO ROTATOR CUFF FAILURE AND LOOSE GLENOID COMPONENT. SURGEON STATED THAT AT THE TIME OF THE PRIMARY IMPLANTATION, THE PATIENT HAD UNDIAGNOSED INFLAMMATORY ARTHROPATHY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Inflammation
MAUDE report 13087667 ↗InjuryDec 10, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 12975001 ↗InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Pain
MAUDE report 12474517 ↗InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 11835713 ↗InjuryNov 11, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT RECEIVED AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY A YEAR AGO. SUBSEQUENTLY A REVISION OCCURRED ABOUT 2 MONTHS AGO DUE TO A LOOSENING BASEPLATE AND BONE EROSION.
Patient problems: Failure of Implant
MAUDE report 9307716 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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