INHANCE 5505-40-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295547174), received between Aug 30, 2023 and Apr 8, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE BASE PLATE WAS NOT EXPLANTED. LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2024. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24819006 ↗
• InjuryOct 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO GLENOSPHERE BEING DISLODGED FROM BASEPLATE. THE LOCKING SCREW WAS STILL SCREWED INTO BASEPLATE WITH NO DAMAGE TO ANY OF THE THREADS. IT WAS STATED THAT THE GLENOSPHERE WERE LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 23346657 ↗
• InjuryJul 29, 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: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22644972 ↗
• InjuryJul 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT SHOULDER PROSTHETIC JOINT DISLOCATION, DEVICE RELATED: NO INFORMATION PROVIDED, PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 25 JUN 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: SHOULDER REDUCTION UNDER SEDATION. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550000440, LOT NUMBER ID: 663562, COMPONENT TYPE: SHELL, DEVICE DESCRIPTION: INHANCE SHOULDER SYSTEM REVERSE HUMERAL SHELL X-LARGE Ø44+0MM. CATALOG NUMBER: 550011290, LOT NUMBER ID: 663627, COMPONENT TYPE: BASEPLATE, DEVICE DESCRIPTION: INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE LARGE Ø29MM CEMENTLESS. CATALOG NUMBER: 550300500, LOT NUMBER ID: 229405, COMPONENT TYPE: SCREW, DEVICE DESCRIPTION: INHANCE SHOULDER SYSTEM SELF-DRILLING & LOCKING SCREW 4 PACK 20MM & 25MM. CATALOG NUMBER: 550040600, LOT NUMBER ID: 220792, COMPONENT TYPE: SCREW, DEVICE DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 40MM. CATALOG NUMBER: 550540008, LOT NUMBER ID: 351163, COMPONENT TYPE: GLENOSPHERE, DEVICE DESCRIPTION: INHANCE SHOULDER SYSTEM GLENOSPHERE Ø40+8MM.

  Patient problems: Joint Dislocation

  MAUDE report 22518695 ↗
• InjuryMar 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO POSTOPERATIVE DISASSOCIATION OF A GLENOSPHERE OF A REVERSE TOTAL SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 21575453 ↗
• InjuryJan 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD THEIR ORIGINAL SURGERY (B)(6) 2024. WHILE AT THE GYM THROWING AROUND A 15LB WEIGHT, PATIENT FELT A POP IN HIS SHOULDER. THE SURGEON BROUGHT PATIENT IN ON (B)(6) 2024 TO REVISE HIS LEFT SHOULDER BECAUSE THE GLENOSPHERE HAD DISASSOCIATED FROM THE BASEPLATE. AFTER REMOVING THIS IMPLANT, SURGEON NOTICED THAT THE SAFETY SCREW HOUSED WITHIN THE GLENOSPHERE STILL SEEMED TO BE SET INTO THE GLENOSPHERE AND THE THREADS NEVER ENGAGED THE BASEPLATE. SURGEON REMOVED THIS IMPLANT, AND PLACED A NEW ONE WITH NO ISSUE. THE TAPER ENGAGED, AND THE SAFETY SCREW WAS SCREWED INTO THE BASEPLATE WITH NO INCIDENT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 21115294 ↗
• InjuryNov 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT : NO SURGICAL DELAY TO REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 20750861 ↗
• InjuryNov 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT RIGHT SHOULDER WAS REVISED ON (B)(6) 2024 DUE TO CONTINUING POST-OP DISLOCATION. SURGICAL DELAY UNKNOWN. DATE OF IMPLANT (B)(6) 2024.

  Patient problems: Joint Dislocation

  MAUDE report 20675895 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT INITIAL SURGERY WAS DONE (B)(6) 2023 BY THE SURGEON AT HOSPITAL. PATIENT WAS THEN REVISED DUE TO INSTABILITY ON (B)(6)2023. UNFORTUNATELY THE PATIENT CAME BACK AGAIN, BUT THIS TIME FOR INFECTION. ALL IMPLANTS WERE REMOVED AND THE SHOULDER WAS THOROUGHLY WASHED. THERE WAS NO SURGICAL DELAYS OR ADVERSE EVENTS TOOK PLACE. THE SHOULDER WAS CLOSED AFTER A THOROUGH WASHOUT. DOI: (B)(6) 2023. DOR: UNKNOWN. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 18940839 ↗
• InjuryJan 3, 2024Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT HAD THE SHOULDER DONE BY SURGEON ON (B)(6) 2023 AT THE HOSPITAL. PATIENT WAS PICKING UP THEIR GRANDCHILD AND THEIR SHOULDER DISLOCATED. AFTER REDUCING IT WITH A FAMILY MEMBER, THEY COULD HEAR AND FEEL A GRINDING IN HIS SHOULDER. THE SURGEON FELT THE POLY HAD COME DISASSOCIATED FROM THE HUMERAL SHELL. THE GRINDING WAS THE GLENOSPHERE AND SHELL GRINDING TOGETHER. THE SURGEON FELT THEY WOULD BENEFIT FROM AN EXCHANGE OF THE POLY, HUMERAL SHELL, AND GLENOSPHERE. THE NEW IMPLANTS WERE OPENED AND IMPLANTED AND THE SHOULDER WAS THOROUGHLY WASHED OUT. STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 18433947 ↗
• MalfunctionAug 30, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE 20 STAR DRIVER TIP BROKE OFF WHILE INSERTING METAGLENE COULD NOT RETRIEVE AND LODGED INTO SET SCREW HEAD. ENDED UP PULLING METAGLENE IMPLANT OFF WHILE IN THE PROCESS INSERTER TIP COLD WELDED INTO GLENOSPHERE. HAD TO IMPLANT NEW GLENOSPHERE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652537 ↗