INHANCE 5200-01-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295538202), received between Apr 20, 2022 and May 12, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Migration

  IT WAS REPORTED THAT PATIENT HAD REVISION DUE TO STEM VERSION. DOI: ON (B)(6) 2026, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 25149196 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NEED MORE STABILITY DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 25001639 ↗
• InjuryApr 21, 2026Use of Device Problem

  IT WAS REPORTED THAT MEDIUM SHORT STEM INHANCE, 36+0 POLY AND MEDIUM +0 SHELL REVISING BECAUSE POLY KEPT SLIPPING OUT AND STEM WAS LEFT PROUD. DOI-UNKNOWN DOR-(B)(6) 2026 AFFECTED SIDE-UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24945442 ↗
• InjuryDec 30, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE DISTAL TIP OF HUMERAL STEM PERFORATED THE HUMERUS. IT WAS REMOVED AND REPLACED WITH A STD STEM. GLENOSPHERE, CUP AND POLY WERE ALSO REPLACED. THERE WAS A LOOSENING OF HUMERAL STEM AT NON-CEMENTED INTERFACE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 23924093 ↗
• 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 23707221 ↗
• InjuryJul 8, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. THERE WAS LOOSENING OF HUMERAL STEM. THE LOOSENING INTERFACE WAS NON-CEMENTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22437394 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 21902710 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PATIENT HAD THEIR ORIGINAL SHOULDER DONE, THE SHOULDER BECOME DISLOCATED. ACCORDING TO SURGICAL IMPLANT RECORDS, THE PATIENT WAS IMPLANTED WITH A 40+8 GLENOSPHERE, MEDIUM +8 SHELL, AND A 40 +4 RETENTIVE POLY. WITH THAT CONSTRUCT PRETTY MUCH MAXED OUT, THE SURGEON FELT THE PATIENT'S HUMERAL COMPONENTS WOULD NEED TO BE REVISED AS A WHOLE. THE HUMERAL STEM WAS REMOVED AND THE PATIENT WAS THEN PREPPED FOR A BIOMET HUMERAL COMPONENT. WITH THE BASEPLATE WELL FIXED, THE SURGEON OPTED TO LEAVE IT AND PLACE A 40+8 ECCENTRIC GLENOSPHERE. ONCE THE BIOMET PREP WAS COMPLETE, THE SHOULDER WAS REDUCED AND PUT THROUGH A FULL RANGE OF MOTION AND FOUND TO BE STABLE. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 20750854 ↗
• MalfunctionApr 22, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE GLENOSPHERE WOULD NOT ENGAGE OR SEAT TO THE BASEPLATE. ADDITIONALLY, THE HUMERAL SHELL AND SHORT STEMS TAPER WOULD NOT PROPERLY ENGAGE AND WAS UNEVEN. NO SURGICAL TIME WAS ADDED. DOE: (B)(6) 2024 AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 19151519 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO BONE FRACTURE IN HUMERUS. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 18236740 ↗
• InjuryNov 20, 2023Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT PATIENT WAS REVISED INHNACE REVERSE HUMERAL COMPONENTS. POSSIBLE LOOSENING OF STEM-APPEARED TO HAVE FALLEN INTO VARUS. PATIENT COMPLAINS OF PAIN PER MD. NO OTHER INFORMATION KNOWN. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 18172977 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO STEM STICKING OUT OF THE POSTERIOR ASPECT OF THE HUMERUS. SURGEON HAD TO REMOVE HEAD, STEM, AND ADAPTER AND WENT WITH A LONGER UNITE STEM AND HEAD IN ORDER TO BRIDGE THE GAP. SURGEON CHOSE TO KEEP THE EXISTING GLENOID, ONLY REVISED HUMERAL COMPONENTS. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 14159574 ↗