Hybrid Glenoid 113952Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00880304462625), received between Mar 12, 2021 and Nov 25, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2024Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.

  Patient problems: Bone Fracture(s); Failure of Implant; Metal Related Pathology; Pain

  MAUDE report 20772548 ↗
• InjuryMar 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED UNDERWENT A REVISION PROCEDURE TO A REVERSE TOTAL SHOULDER FOR INSTABILITY AND TWO EVENTS OF LUXATION APPROXIMATELY TWO YEARS POST INITIAL PROCEDURE. ALL COMPONENTS, EXCEPT FOR STEM, WAS REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Subluxation

  MAUDE report 18866428 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ANATOMIC SHOULDER REPLACEMENT ONE (1) YEAR AND NINE MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO THE PATIENT'S ROTATOR CUFF FAILING. THE IMPLANT WAS EXPLANTED, AND A MINI BASEPLATE WAS IMPLANTED ALONG WITH A GLENOSPHERE, SCREWS, AND MINI HUMERAL TRAY AND BEARING.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 18226903 ↗
• InjuryJun 7, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT AN INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED APPROXIMATELY 3 YEARS AGO. SUBSEQUENTLY, THE PATIENT REPORTED TO HER SURGEON THAT SHE HAD BEEN DOING FINE UNTIL SHE REACHED DOWN TO GRAB SOMETHING AND FELT A PAIN IN HER LEFT SHOULDER. FOLLOW UP RADIOLOGY CONFIRMED FRACTURE OF THE CENTRAL SCREW WITH SUBSEQUENT LOOSENING AND OSTEOLYSIS FROM DEBRIS GENERATION. THE PATIENT REPORTS SHE HAS SINCE HAD PAIN, DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, AND LIMITED RANGE OF MOTION. THE PATIENT WAS REVISED TO A REVERSE TOTAL SHOULDER APPROXIMATELY A YEAR AND A HALF AGO DUE TO GLENOID IMPLANT FRACTURE. DURING THE REVISION, EVIDENCE OF METALLOSIS AND WEAR WERE FOUND AS WELL AS CYSTIC DEFECTS AND SIGNIFICANT SCAR TISSUE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH UNKNOWN PRODUCT EXCEPT FOR SPECIFYING IMPLANTATION OF A BIOMET BASE PLATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME AND THE STUDY IS NOW COMPLETE.

  Patient problems: Cyst(s); Failure of Implant; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Subluxation

  MAUDE report 17081265 ↗
• InjuryJan 31, 2023Unstable; Naturally Worn; Noise, Audible; Unstable; Naturally Worn; Noise, Audible

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT SHOULDER REVISION APPROXIMATELY FOUR(4) YEARS POST IMPLANTATION DUE TO POSTERIOR INSTABILITY, PAIN AND NOISE. DURING THE REVISION THE LEFT SHOULDER WAS FOUND TO HAVE DEGENERATIVE JOINT DISEASE, ROTATOR CUFF ARTHROPATHY, AN IRREPARABLE ROTATOR CUFF TEAR, AND SUB LUXATION OF HUMERAL HEAD. ALL COMPONENTS, EXCEPT THE HUMERAL STEM, WERE REMOVED AND REPLACED WITH ZIMMER BIOMET PRODUCT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Arthritis; Failure of Implant; Joint Laxity; Muscle/Tendon Damage; Pain; Subluxation

  MAUDE report 16270821 ↗
• InjuryOct 25, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY DUE TO BONE EROSION AND INSTABILITY ON AN UNKNOWN DATE. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

  Patient problems: Erosion; Failure of Implant

  MAUDE report 15670160 ↗
• InjurySep 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 20 MONTHS POST IMPLANTATION AFTER A SUDDEN ONSET OF PAIN AND POP IN THE SHOULDER.  DURING THE REVISION, THE SURGEON EXCISED SCAR TISSUE, SYNOVITIS, AND ADVERSE TISSUE REACTION.  THE GLENOID WAS FLOATING FREE IN THE JOINT AND FRACTURED THROUGH THE METAL STEM WITHIN THE GLENOID VAULT.  THE GLENOID POST, GLENOID, ADAPTER, AND HEAD WERE REVISED.  THE STEM WAS RETAINED.  ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Pain; Scar Tissue; Synovitis

  MAUDE report 15335871 ↗
• InjuryAug 29, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAD REVISION SURGERY APPROXIMATELY ONE (1) YEAR AND EIGHT (8) MONTHS AFTER THE INITIAL SURGERY DUE TO PAIN, LOSS OF RANGE OF MOTION, AND LOOSENING OF THE IMPLANTS.

  Patient problems: Joint Dislocation; Loss of Range of Motion; Pain

  MAUDE report 15310365 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY FOR AN UNKNOWN REASON ON AN UNKNOWN DATE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15310261 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS BEING CONSIDERED FOR A REVISION SURGERY DUE TO FAILURE OF THEIR SUBSCAPULARIS THAT LEAD TO THE PATIENT'S GLENO HUMERAL JOINT UNSTABLE.

  Patient problems: Muscle/Tendon Damage; Osteolysis

  MAUDE report 15258389 ↗
• InjuryAug 4, 2022Fracture; Detachment of Device or Device Component; Naturally Worn; Fracture; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2.5 YEARS POST IMPLANTATION DUE TO DISASSOCIATION OF THE GLENOID AND METAL POST. FURTHER INFORMATION IS UNAVAILABLE.

  Patient problems: Failure of Implant; Loss of Range of Motion; Pain

  MAUDE report 15163284 ↗
• InjurySep 1, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant

  MAUDE report 12406463 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 11841878 ↗
• InjuryMar 12, 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: Pain

  MAUDE report 11472665 ↗