INHANCE 5505-36-104Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295547082), received between Jan 10, 2024 and Jun 22, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A CHRONIC DISLOCATION A COUPLE MONTHS AFTER SURGERY. DR FOUND IT BEST TO REMOVE THE GLENOSPHERE/POLY AND INCREASE FROM A 36 TO A 40 TO HELP WITH THIS PROBLEM. THERE WAS NO MORE INFORMATION AVAILABLE AT THIS TIME. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 25577748 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR POOR ACTIVE MOTION, POSSIBLE AXILLARY NERVE INJURY, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NOT RELATED, PROCEDURE RELATED: POSSIBLE, DATE OF EVENT: (B)(6) 2026, DATE OF IMPLANT: (B)(6) 2026, DATE OF REVISION: NO INTERVENTION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: DIAGNOSTIC INTERVENTION: YES, SPECIFY: NCV/EMG. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550036100, LOT NUMBER: MI191184, COMPONENT TYPE: LINER, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550310015, LOT NUMBER: 230230, COMPONENT TYPE: SCREW, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550000360, LOT NUMBER: 661634, COMPONENT TYPE: SHELL, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550536104, LOT NUMBER: 351208, COMPONENT TYPE: GLENOSPHERE, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 520000036, LOT NUMBER: 662988, COMPONENT TYPE: HUMERAL, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550310030, LOT NUMBER: 239924, COMPONENT TYPE: SCREW, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550310020, LOT NUMBER: 219917, COMPONENT TYPE: SCREW, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550025600, LOT NUMBER: 234397, COMPONENT TYPE: SCREW, UNIQUE

  Patient problems: Loss of Range of Motion; Nerve Damage

  MAUDE report 25324924 ↗
• InjuryFeb 20, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS REOCCURRING DISLOCATION, ROTATOR CUFF REPAIR COMPROMISED. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation; Unspecified Tissue Injury

  MAUDE report 24403171 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REVISION DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 24304340 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LOOSE BASEPLATE WAS REMOVED AND REVISED TO DJO BASEPLATE, WHICH WAS THEN PAIRED WITH A DEPUY STEM. THE EVENT PROMPTED EVALUATION FOR INFECTION. ALL COMPONENTS EXCEPT THE STEM WERE REMOVED, AND THERE WAS NO CASE DELAY. THE IMPLANTS WERE SENT TO PATHOLOGY, DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE- LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 23781117 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REVISION WAS FOR INSTABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 23658189 ↗
• 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: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22615752 ↗
• InjuryJun 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT SHOULDER WAS DISLOCATING. GLENOSPHERE ROTATED. IT MAAY NOT HAVE BEEN SCREWED DOWN COMPLETELY. DOI: (B)(6) 2024 DOR: (B)(6) 2025 AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22338237 ↗
• InjuryJun 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A REVERSE SHOULDER DONE IN (B)(6) 2024 AND HAD SEVERAL DISLOCATIONS. SURGEON WENT BACK, REVISED THE HEAD AND HUMERAL SHELL. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22309677 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO SURGICAL DELAY. B. WHAT WAS THE REASON FOR REPLACING THE GLENOSPHERE AND THE CUP? HAD TO REMOVE TO GET SCREWS OUT AND PUT NEW IMPLANTS IN.

  Patient problems: Pain

  MAUDE report 20653764 ↗
• InjurySep 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATIONS. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 20318046 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 19772752 ↗
• InjuryJul 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATIONS. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 19741765 ↗
• InjuryJan 10, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  SHOULDER OF THE PATIENT WAS REVISED DUE TO GLENOSPHERE CAME OFF OF THE GLENOID BASEPLATE AND THE GLENOSPHERE SCREW WAS LEFT IN THE BASEPLATE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18483256 ↗