INHANCE 5100-24-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295538158), received between Dec 9, 2022 and Apr 8, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND TORE ROTATOR CUFF. CONVERTED TO REVERSE TOTAL SHOULDER. NO ADVERSE PATIENT OUTCOMES OR TIME SPENT. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24818674 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CONVERSION TO REVERSE DUE TO SUBSCAP FAILURE. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24802277 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TORE THEIR ROTATOR CUFF. NEEDED TO SWITCH TO A REVERSE. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24745221 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SUFFERED A ROTATOR CUFF FAILURE. PATIENT NEEDED TO HAVE THEIR SHOULDER CONVERTED TO A REVERSE. ANATOMIC IMPLANTS WERE REMOVED AND SHOULDER WAS PREPARED AND IMPLANTED WITH REVERSE COMPONENTS. SHOULDER STABILITY WAS CONFIRMED. THERE WAS NO DELAYS OR ADVERSE EVENTS TOOK PLACE. DOI: (B)(6) 2023, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24414227 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ENHANCE ANATOMIC PROCEDURE IN (B)(6). UNFORTUNATELY, PATIENT'S SUBSCAP TENDON WENT ON TO FAILURE. PATIENT WAS REVISED TO A REVERSE ENHANCE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23782794 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO A REVERSE FROM ANATOMIC DUE TO CUFF FAILURE. THERE WAS NO IMPLANT FAILURE AND NO BROKEN PIECES. THERE WAS NO DELAY. NO OTHER INFORMATION KNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2025 . AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23555888 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ANATOMIC SHOULDER DONE; HOWEVER, EXHIBITED SIGNS OF CUFF TEAR ARTHROPATHY. SURGEON REVISED COMPONENTS TO A REVERSE. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23414076 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT TORE THEIR ROTATOR CUFF AND REVERSE WAS NEEDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23029072 ↗
• InjurySep 2, 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 CONVERSION TO REVERSE SHOULDER BECAUSE OF CUFF TEAR. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22938505 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FAILED SUBSCAP REPAIR FOLLOWING TSA. REVISED TO REVERSE SHOULDER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22914381 ↗
• InjuryAug 28, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE GLENOID WAS LOOSE, SURGEON REMOVED GLENOID AND HUMERAL COMPONENT AND DID A REVERSE TOTAL SHOULDER. THE INHANCE GLENOID WAS LOOSE. LOOSENING INTERFACE WAS NOT APPLICABLE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 22912936 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A FAILED ROTATOR CUFF. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22299516 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INJURY AND CUFF TEAR. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22299188 ↗
• InjuryMay 20, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LEFT SHOULDER PAIN. THERE WAS LOOSENING OF THE GLENOID COMPONENT AT THE CEMENT/IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 22055274 ↗
• InjuryMay 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SHOULDER AND NECK PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Pain

  MAUDE report 22041085 ↗
• 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 21921740 ↗
• InjuryDec 12, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR LOOSE GLENOID AND STEM. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 20917911 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBSCAPULARIS WAS FAILED AND CONVERSION TO REVERSE TOTAL SHOULDER. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20427620 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ROTATOR CUFF TEAR. DOI: ON (B)(6) 2023. DOR: ON (B)(6) 2024. AFFECTED SIDE : RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19829516 ↗
• InjuryMar 18, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF GLENOID AT THE CEMENT TO IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 18920533 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ROTATOR CUFF PAIN. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE : RIGHT SHOULDER.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 18907234 ↗
• InjuryAug 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS CONVERTED TO A REVERSE SHOULDER AS THE SURGEON STATED THAT HE BELIEVED THE PATIENT TORE HER RC DURING THERAPY AND MADE THE JOINT UNSTABLE AND WAS ROCKING THE GLENOID IMPLANT AND IT LOOSENED AND BECAME DISLODGED. LOOSENING OF THE GLENOID COMPONENT AT THE BONE TO CEMENT INTERFACE WAS REPORTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023, DOR:(B)(6) 2023 AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 17606866 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STABILITY ISSUES THAT WERE NOT IMPLANT RELATED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 15953005 ↗