INHANCE 5505-40-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295547150), received between Dec 11, 2023 and Feb 24, 2026 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD TWO DISLOCATIONS. IT WAS REVISED FOR INSTABILITY. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 24427921 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE SUBLUXATION EVENT. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: PROBABLE. DATE OF EVENT: 20 DEC 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: OTHER NON-SURGICAL TREATMENTS: YES. (SPECIFY: HOLD FORMAL PT AND RESUME USING THE SHOULDER IMMOBILIZER FOR THE NEXT 3 WEEKS. HE CAN DO PENDULUM EXERCISES BUT WILL HOLD ON TO THE REMAINDER OF HIS HOME EXERCISE PROGRAM. IN THREE WEEKS, HE CAN WEAN FROM THE IMMOBILIZER AGAIN AND RESUME OUTPATIENT PT.)

  Patient problems: Joint Laxity

  MAUDE report 24042719 ↗
• InjuryJan 8, 2026Fracture; Device 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 24002919 ↗
• MalfunctionOct 29, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE GLENOSPHERE SCREW WOULDN'T ENGAGE. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414314 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23026590 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GROSSLY INFECTED HAD TO REMOVE IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22977676 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS 3 WEEKS POST-OP FROM A REVERSE TOTAL SHOULDER ARTHROPLASTY. THE WOUND WAS OOZING AND LABS INDICATED THE PRESENCE OF INFECTION. THIS PROCEDURE WAS I&D WITH HARDWARE EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 22588576 ↗
• InjuryJun 18, 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 INSTABILITY. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22283494 ↗
• InjuryJun 18, 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 INSTABILITY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22283435 ↗
• InjuryMar 7, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT CAME IN COMPLAINING OF PAIN A 1-2 WEEKS AGO. A CT SCAN WAS DONE AND IT WAS DISCOVERED THAT THE ENHANCE REVERSE LINER COULD BE SEEN FLOATING IN THE SHOULDER AND WAS NOT ATTACHED TO THE HUMERAL SHELL/STEM CONSTRUCT. IT ALSO SHOWED WHAT APPEARED TO BE METALLOSIS INDICATING THAT THE GLENOSPHERE HAD BEEN RUBBING ON THE FACE OF THE HUMERAL SHELL. REVISION SURGERY WAS DONE ON (B)(6) 2025. THERE WAS A SIGNIFICANT AMOUNT OF METAL DEBRIS AND METALLOSIS ON THE BONE AND THE SURROUNDING TISSUE. IT IS UNKNOWN HOW LONG THE POLY HAD BEEN OUT OF PLACE BUT BY THE DAMAGE DONE TO THE IMPLANTS AS WELL AS THE AMOUNT OF METALLOSIS, IT SEEMED TO HAVE HAPPENED QUITE A WHILE BACK. THE GLENOSPHERE HAD WORN A DIVOT IN THE FACE OF THE SHELL. SURGEON WAS ABLE TO REMOVE THE GLENOSPHERE, THE HUMERAL SHELL, THE STEM, AND RETRIEVED THE POLY. THE BASEPLATE AND SCREWS WERE WELL FIXED AND STAYED IMPLANTED. THE SURGEON CLEANED/REMOVED THE METAL DEBRIS AND METALLOSIS OUT OF THE BONE AND TISSUE. THE SURGEON WAS ABLE TO REVISE TO A LARGER AND LONGER STEM AND ACHIEVE GOOD FIXATION, HE PUT ON A NEW GLENOSPHERE OF THE SAME SIZE AND TRAILED A FEW HUMERAL SHELL AND POLY COMBINATIONS TO DETERMIN

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 21551959 ↗
• InjuryOct 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT CLAIMS THAT THEY DISLOCATED THEIR SHOULDER BY SWEEPING AND HAD SEVERAL PREVIOUS INSTANCES OF WHAT FELT LIKE DISLOCATION PRIOR TO THE COMPLETE DISLOCATION. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 20398345 ↗
• MalfunctionApr 1, 2024Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THAT THE GLENOSPHERE WOULD NOT THREAD INTO BASEPLATE. INSERTER HANDLE WAS DAMAGED WOULD NOT THREAD INTO GLENOSPHERE IMPACTOR TIP. CAN¿T BE 100% SURE ON IMPACTOR TIP, MIGHT HAVE BEEN DAMAGED AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19012286 ↗
• MalfunctionDec 11, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT SEVERAL ATTEMPTS TO PLACE GLENOSPHERE WERE TAKEN. WHEN DOCTOR PULLED IT WAS SOLID PIT WHEN HE WOULD TWIST IT WAS LOOSE. DOCTOR TRIED TO PERIPHERAL REAM AGAIN, DOCTOR CHECKED THE PERIPHERAL SCREWS WITH CHECKER AND THEY DID NOT SEEM TO BE PROUD. DOCTOR RE TIGHTENED THE PERIPHERAL SCREWS AND GAS THE SAME ISSUES WITH THE GLENOSPHERE AGAIN. THEY SWITCHED GLENOSPHERE INSERTER TIPS AND AGAIN THE SAME ISSUES. SURGEON RE CHECKED HIS POSITIONING AND STILL THE SAME ISSUES. DOCTOR THEN PUT THE TRIAL GLENOSPHERE BACK ON AND HAD NO ISSUES WITH IT SEATING APPROXIMATELY. HE THEN PLACED A TRIAL 40+8MM GLENOSPHERE AND IT SEATED APPROXIMATELY. HE THEN ASKED FOR THE 40+8MM GLENOSPHERE IMPLANT AND WAS ABLE TO GET IT TO PROPERLY SEAT. NO EXPECTED PATIENT OUTCOMES, SURGEON WAS HAPPY WITH PATIENTS ROM & X-RAYS. THIS GLENOSPHERE ISSUE CAUSED ABOUT A 30 MINUTE DELAY. DOE: NOV 28, 2023 AFFECTED SIDE: RIGHT SHOULDER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300017 ↗