INHANCE 5505-40-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295547181), received between Jul 10, 2024 and Nov 13, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT WAS IMPLANTED WITH A INHANCE SHOULDER CONSTRUCT. PATIENT WAS DOING GOOD AT FIRST AND THEN FELT DISCOMFORT RECENTLY. PATIENT WENT TO THE EMERGENCY ROOM WHERE INFECTION WAS DIAGNOSED. SURGEON DID I&D AND EXCHANGED THE GLENOSPHERE, SHELL, AND THE POLY. THE HUMERAL STEM, BASEPLATE WERE LEFT IN SITU. DOI: (B)(6) 2025, DOR: UNKNOWN, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 23545258 ↗
• InjuryDec 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT CAME BACK FOR REVISION ON (B)(6) 2024 AFTER DISLOCATING ANTERIORLY FROM A REVERSE TOTAL SHOULDER PERFORMED ON (B)(6) 2024. THE SURGEON FOUND IT BEST TO REMOVE THE EXISTING POLY AND GLENOSPHERE, CLEAR OUT ANY BONE AROUND THE AREA THAT COULD CAUSE LEVERING AND RETRIAL A 40 +8 ECC GLENOSPHERE IN DIFFERENT ORIENTATIONS WITH A RETENTIVE POLY UNTIL STABILITY IS PROPERLY GAINED. AFTER TRIALING HE REIMPLANTED A 40 +8 ECC GLENOSPHERE WITH A 40 +0MM RETENTIVE POLY. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 20820874 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT I&D WITH THE GLENOSPHERE, HUMERAL SHELL AND POLY EXCHANGE FOR CONFIRMED INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 20409836 ↗
• InjuryAug 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 19940413 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIS RIGHT SHOULDER REPLACED BY THE PRIMARY SURGEON ON (B)(6) 2022 WHERE HE RECEIVED A DELTA EXTEND REVERSE SHOULDER CONSTRUCT. HE CAME TO THE REVISING SURGEON EARLIER THIS YEAR WITH SHOULDER PAIN WHERE THE SURGEON REVISED THE CONSTRUCT BECAUSE OF A LOOSE BASEPLATE. UNFORTUNATELY, THE PATIENT SHOULDER BECAME INFECTED FOLLOWING THE REVISION. THE REVISING SURGEON THEN REVISED THE SHOULDER AND EXPLANTED ALL OF THE COMPONENTS AND IMPLANTED A ANTIBIOTIC SPACER. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 19710815 ↗