INHANCE 5500-01-240Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295546634), received between Mar 15, 2023 and Sep 15, 2026 — classified as 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revision due to infection/fracture from fall.DOI: (b)(6) 2025.DOR: (b)(6) 2026.Affected Side: Right.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 50771475 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 24568075 ↗
• InjuryJan 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT INITIAL IMPLANTATION ON (B)(6) 2024. ON (B)(6) 2025 THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISSOCIATION OF THE GLENOSPHERE AND THE CENTRAL SCREW, PERIPHERAL SCREWS, HUMERAL TRAY AND LINER WERE REPLACED. ON (B)(6) 2025, THE PATIENT UNDERWENT ANOTHER REVISION PROCEDURE DUE TO DISSOCIATION OF THE GLENOSPHERE. THE GLENOSPHERE DISASSOCIATED FROM THE GLENOID BASEPLATE AND CENTRAL SCREW POST WITH THE SCREW POST REMAINING IN THE BASEPLATE. THE BASEPLATE WAS REPLACED IN THE GLENOSPHERE AND THE TRAY AND LINER WERE USED TO CREATE THE APPROPRIATE TENSION OF THE SHOULDER. DOI- (B)(6) 2025. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 24002979 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COMPONENTS WERE REMOVED DUE TO LOCKING SCREW BEING BROKEN & INFECTION OF THE JOINT. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22615708 ↗
• InjuryJul 24, 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 INFECTION. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22594416 ↗
• MalfunctionMay 29, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHILE INSERTING A SMALL MODULAR BASEPLATE AND LOCKING SCREW INFERIORLY, THE LOCKING SCREW DID NOT CATCH IN THE BASEPLATE; IT SUNK THROUGH. ANOTHER LOCKING SCREW WAS TRIED, AND IT DID THE SAME THING. THE BASEPLATE WAS LEFT IN PLACE ALONG WITH THE SECOND LOCKING SCREW. TWO PERIPHERAL SCREWS WERE ALSO PLACED; THEY LOCKED IN WITH NO ISSUES. DOE: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22108295 ↗
• InjuryJan 22, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT WAS REVISED DUE TO GLENOID IMPLANT POSITION. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 21210211 ↗
• InjuryNov 12, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE GLENOID COMPONENT FAILED. THERE WAS LOOSENING OF THE GLENOSPHERE AND BASEPLATE. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024 AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20663104 ↗
• MalfunctionOct 24, 2024Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 20521116 ↗
• MalfunctionOct 17, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE BASEPLATE ROD AND HANDLE WAS CROSS THREADED ON TO THE BASEPLATE THEN COLD WELDED AFTER IMPACTED. A SECOND BASEPLATE ROD WAS ATTEMPTED TO THREAD ON TO A SECOND GLENOSPHERE INSERTER TIP BUT THE ROD THREADS WERE WORN AND IT WOULDN¿T THREAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471611 ↗
• 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 19711446 ↗
• InjuryJul 10, 2024Osseointegration Problem; Osseointegration 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) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19710200 ↗
• InjuryJun 20, 2024Adverse 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 PAIN. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 19574823 ↗
• InjuryJul 14, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO GLENOID COMPONENT LOOSENING. SURGEON STATES IT WAS DUE TO POOR BONE QUALITY. ENTIRE CONSTRUCT WAS REMOVED AND DELTA XTEND W/ CTA HEAD WAS PUT INTO PLACE DUE TO POOR BONE QUALITY. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17324523 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WAS SUSPICION OF INFECTION. IT IS UNKNOWN IF INFECTION WAS PRESENT. IMPLANTS WERE REMOVED. IT WAS THEN WASHED OUT AND NEW IMPLANTS WERE INSERTED. DOI: (B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17297780 ↗
• InjuryMay 15, 2023Osseointegration Problem; Osseointegration Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING. DOI: (B)(6) 2023; DOR: (B)(6) 2023; RIGHT SHOULDER. TREATMENT: METAGLENE AND GLENOSPHERE WERE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16935707 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS BEING REVISED DUE TO PAIN AND DISCOMFORT IN THEIR SHOULDER. DR INFORMED THAT THE PATIENT FELT A POP FOLLOWED BY PAIN AFTER LIFTING SOMETHING ABOVE THEIR HEAD. DR.¿S PA INFORMED THAT THERE MAY HAVE BEEN A FRACTURE OF THE PATIENTS GLENOID. DR REMOVED THE GLENOID AND HUMERAL COMPONENTS AND OPTED TO REVISE THE PATIENT WITH ZIMMER-BIOMET IMPLANTS. ONCE THE IMPLANTS WERE REMOVED, DR TOLD THE REP THAT HE WOULD BE GOING WITH ZIMMER-BIOMET, AND THAT HE NO LONGER NEEDED REP'S ASSISTANCE IN THE ROOM. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022 DOR: (B)(6) 2023 AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Bone Fracture(s); Discomfort; Pain

  MAUDE report 16544453 ↗