INHANCE 5200-42-145Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295538325), received between Jul 12, 2023 and Jun 25, 2026 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL RIGHT TOTAL SHOULDER. PATIENT'S SHOULDER WAS CONVERTED FROM ANATOMIC TO REVERSE SHOULDER. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 25627996 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED TO A REVERSE DUE TO INSTABILITY. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 25256794 ↗
• 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 24790331 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WAS DISSATISFIED WITH POST-OP IMAGING AND DECIDED TO PERFORM A REVISION PROCEDURE. THE EVENT DID NOT OCCUR DURING SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 23783521 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TORE ROTATOR CUFF. CONVERTED TO A REVERSE. NO IMPLANT FAILURE OR LOOSENING. DOI: UNKNOWN. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21921739 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TSA WITH INHANCE STEMLESS AND GLENOID. AT THAT TIME THE CASE WAS SCHEDULED AS TSA VS RTSA DUE TO THE QUALITY OF THE SUBSCAP. IT WAS DECIDED THE SUBSCAP HAD FAILED AND THE PATIENT HAD EXPLANTAION OF INHANCE TSA, ALL COMPONENTS, WITH CONVERSION TO ARTHREX REVERSE TSA. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17309489 ↗