INHANCE 5200-01-028Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295538233), received between Dec 1, 2022 and Jul 27, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that soft tissue failed. No mechanical issue with implants.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Unknown.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50045709 ↗
• MalfunctionFeb 26, 2026Device Contaminated During Manufacture or Shipping; Missing Information

  IT WAS REPORTED THERE IS A DAMAGED SHIPMENT. THE BOX LOOKS SOMEWHAT CRUSHED AND THE SEAL ON THE BACK HAS BEEN CUT OPEN AND THE STICKERS HAVE BEEN REMOVED FROM THE OUTSIDE OF THE STERILE POUCH. THE IFU IS NOT IN THE BOX. THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461289 ↗
• InjuryDec 4, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN OLD FRACTURE BEFORE HER FIRST SURGERY AND MADE FOR DIFFICULT HUMERAL PREP DURING APEX PROCEDURE. THE SURGEON STATED THE PATIENT FELL AWHILE BACK AND DISLOCATED HER HIP AND SHOULDER DURING THE FALL. THE SURGEON TRIED TO RELOCATE THE SHOULDER CLOSED BUT WAS UNSUCCESSFUL. THE SURGEON ELECTED TO OPEN AND EVALUATE THE SHOULDER. UPON OPENING THE SHOULDER, THE HUMERAL IMPLANT WAS LOOSE BECAUSE OF BONE LOSS. THE HUMERAL COMPONENT WAS LOOSE WITH NON-CEMENTED INTERFACE. THE SURGEON REPLACED WITH A LONGER STEM AND HYBRID FIXATION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration; Unspecified Tissue Injury

  MAUDE report 20843207 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LATERAL HUMERAL CORTEX STEM PERFORATION AND HUMERAL BONE FRACTURE. EVENT IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (LEFT SHOULDER) TREATMENT: REVISION; STEM AND HEAD WERE REVISED.

  Patient problems: Bone Fracture(s)

  MAUDE report 15897520 ↗