INHANCE 5100-26-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295538141), received between May 4, 2023 and Jun 25, 2026 — classified as 17 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. 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 17 most recent of 17 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 25628474 ↗
• InjuryApr 3, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CONVERSION FROM ANATOMIC TSA TO REVERSE TSA DUE TO FAILED LESSER TUBEROSITY OSTEOTOMY (LTO). ROTATOR CUFF WAS COMPROMISED. DOI: (B)(6) 2026. DOR: (B)(6) 2026 AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24779330 ↗
• InjuryMar 4, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO GLENOID LOOSENING. DEPUY SYNTHES CEMENT WAS USED. PATIENT GOT INTO ALTERCATION THAT LED TO SHOULDER PAIN. DETERMINED GLENOID IMPLANT WAS LOOSE. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 24506661 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT PATIENT FELL AND TORE RC. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 23772106 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO CUFF TEAR. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23706957 ↗
• InjuryNov 25, 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 A TORE ROTATOR CUFF AND SUBSCAP DURING REHABILITATION. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23647831 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO FAILED ROTATOR CUFF. WE TOOK OFF THE HEAD AND TAPER ADAPTER AND GLENOID. LEFT THE STEM. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23476651 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED AN SHOULDER. REVISION WAS PERFORMED. IT WAS REPORTED THAT IT WAS NOT RELATED TO ANY DEPUY PRODUCT. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 23371636 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A REVISION FROM ANATOMIC TO REVERSE DUE TO SUBSCAP FAILURE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22581743 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A FAILED PRIMARY TOTAL SHOULDER DUET TO SOFT TISSUE AND MUSCLE DEFICIENCY AND WAS CONVERTED TO A REVERSE TOTAL SHOULDER. DOI: (B)(6) 2023. DOR: FEB 24, 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21683867 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ROTATOR CUFF PAIN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 20189214 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REPLACED THIS PATIENTS SHOULDER IN MAY THIS YEAR WHERE HE RECEIVED A INHANCE ANATOMIC STEMLESS CONSTRUCT. THIS PATIENT UNFORTUNATELY TORE HIS ROTATOR CUFF IN JUNE AND LOST FUNCTION. IT WAS DETERMINED THAT HIS ANATOMIC CONSTRUCT WOULD BE CONVERTED TO A REVERSE CONSTRUCT TO REGAIN FUNCTION AND MOTION. THERE WAS NO SURGICAL DELAY, ADVERSE EVENTS, OR ANY IMPLANT FAILURE TO REPORT. THE STEMLESS COMPONENT WAS RETAINED, THE GLENOID, HUMERAL HEAD, AND TAPER ADAPTOR WERE EXPLANTED AND REVERSE COMPONENTS WERE IMPLANTED. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Loss of Range of Motion; Unspecified Tissue Injury

  MAUDE report 20136641 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SUBSCAP EVULSION AND REQUIRED REVISION TO REVERSE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19816842 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED REVISION WAS COMPLETED DUE TO PAIN. SURGICAL DELAY IS UNKNOWN. DOI- (B)(6) 2023. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 19648332 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SUBSCAPULARIS FAILURE AND THE IMPLANTS WERE CONVERTED TO A REVERSE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18300319 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH SUBSCAP FAILURE DUE TO PATIENT NON COMPLIANCE. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16941782 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SUBSCAPULARIS FAILURE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16873518 ↗