INHANCE 5200-01-044Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295538226), received between Dec 9, 2022 and Jun 12, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Use of Device Problem

  IT WAS REPORTED THAT UPON THE PATIENT LEAVING THE OPERATING ROOM, A POST-OPERATIVE X-RAY REVEALED THE HUMERAL STEM WAS POSITIONED IN VARUS AND HAD PERFORATED THE LATERAL HUMERUS. DOE: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 25488461 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMES IN TODAY HAVING PROBLEMS WITH CHRONIC DISLOCATIONS. THE PATIENT LIFTED A HEAVY BOX 4 WEEKS POST OPERATION AND DISLOCATED CAUSING MORE PROBLEMS. THE DOCTOR DECIDED IT BEST TO REMOVE HIS GLENOSPHERE AND POLY TO REBALANCE THE SHOULDER. WHILE DOING THIS THE PROXIMAL HUMERUS FRACTURED SO HE REMOVED THE STEM AND SHELL AS WELL. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 25056097 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HUMERAL FRACTURE AND LONGER STEM WAS REIMPLEMENTED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 24083027 ↗
• InjuryJan 30, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT HAD INITIAL SURGERY DONE BY THE SURGEON AT THE HOSPITAL ON (B)(6) 2023. PATIENT WAS IMPLANTED WITH DEPUY HUMERAL COMPONENTS, AND BIOMET AUGMENTED GLENOSPHERE. THE GLENOSPHERE BECAME LOSE AND CAME COMPLETELY DISLODGED FROM THE GLENOID. SURGEON WANTED TO CONVERT THE SHOULDER TO A HEMI AND FELT THE HUMERAL SIDE WAS LOSE, SO SURGEON COMPLETELY REMOVED THE DEPUY HUMERAL SIDE AND ENDED UP IMPLANTING A ZIMMER BIOMET HEMI SHOULDER IMPLANT. NO ADVERSE EVENTS TOOK PLACE. DOI: (B)(6) 2023 .DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606171 ↗
• InjuryDec 9, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. NEEDED LONGER STEM. NO ADDITIONAL INFORMATION. THERE WAS A LOOSENING AND LOOSENING INTERFACE WAS NON-CEMENTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 15952967 ↗