INHANCE 5100-26-522Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295549154), received between Jul 8, 2024 and Sep 9, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent a failed rotator cuff conversion to reverse total shoulder arthroplasty.DOI: (b)(6), 2025DOR: (b)(4), 2026Affected side: Left shoulder.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50696065 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ANATOMIC SHOULDER ARTHROPLASTY DONE ON (B)(6) 2025. PATIENT STATED THEY WERE DOING WELL FOR 4-5 MONTHS UNTIL THEY SUDDENLY COULDN¿T LIFT THEIR ARM DUE TO A SUBSCAP TEAR. TODAY, THE PATIENT WAS CONVERTED FROM AN ANATOMIC SHOULDER TO A REVERSE SHOULDER. THE ANATOMIC HUMERAL HEAD WAS REMOVED ALONG WITH THE OFFSET TAPER ADAPTER, THE HYBRID GLENOID WAS REMOVED AND REPLACED WITH A REVERSE BASEPLATE. STEMLESS COMPONENT WAS REMOVED AND REPLACED WITH A STANDARD STEM. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24790327 ↗
• InjuryOct 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT SHOULDER DISLOCATED AFTER REPLACEMENT. CONVERTED TO A REVERSE. AFFECTED SIDE- LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 23393082 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON REMOVED IMPLANTS FOR FAILED ANATOMIC TSA HYBRID ANATOMIC GLENOID. REMOVED AND CONVERTED TO REVERSE. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23369237 ↗
• MalfunctionMay 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS THE MEDIUM HYBRID GLENOID CAME DISSOCIATED FROM TOUCH FREE INSERTER. IT WOULD NOT SNAP BACK ON. THE PLASTIC CONNECTION PIECE WAS TOO LOOSE; IT DIDN'T HOLD IMPLANT. THE PROCEDURE WAS DELAYED FOR ONE MINUTE WHILE A SECOND GLENOID WAS OPENED. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041090 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT TORE ROTATOR CUFF AND SURGEON CONVERTED TO REVERSE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21988028 ↗
• MalfunctionSep 26, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY, UPON OPENING THE INHANCE GLENOID IT WAS FOUND THAT THE CLEAR PLASTIC INSERTER TIP WAS DISENGAGED/DISCONNECTED FROM THE GLENOID. THE NURSE TRIED TO RE-CONNECT THIS INSERTER TIP TO GLENOID, BUT THE CLIPS WOULD NOT GRAB OR HOLD PROPERLY TO THE PERIPHERAL LIP OF THE GLENOID. THIS MADE IT DIFFICULT TO INERT/IMPLANT THE GLENOID INTO THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311778 ↗
• MalfunctionJul 8, 2024Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED: A. PLEASE PROVIDE THE PRODUCT CODE AND LOT NUMBER OF THE UNK INSERTION DEVICE. THE INSERTION DEVICE I REFERENCED IS THE ONE WHICH COMES ATTACHED TO THE IMPLANT. IT DOES NOT HAVE ITS OWN CODE THAT I AM AWARE OF. B. WAS THERE ANY ALLEGATION AGAINST THE SECONDARY IMPACTOR? THERE WAS NO ALLEGATION AGAINST THE SECONDARY IMPACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19688542 ↗
• MalfunctionJul 8, 2024Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED: A. PLEASE PROVIDE THE PRODUCT CODE AND LOT NUMBER OF THE UNK INSERTION DEVICE. THE INSERTION DEVICE I REFERENCED IS THE ONE WHICH COMES ATTACHED TO THE IMPLANT. IT DOES NOT HAVE ITS OWN CODE THAT I AM AWARE OF. B. WAS THERE ANY ALLEGATION AGAINST THE SECONDARY IMPACTOR? THERE WAS NO ALLEGATION AGAINST THE SECONDARY IMPACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19688540 ↗