INHANCE 5500-40-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295546818), received between Jan 3, 2024 and Jun 30, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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.

• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INSTABILITY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 25668331 ↗
• InjuryApr 29, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS REVISION DUE TO DISLOCATION. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 25031389 ↗
• InjuryJan 23, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO INFECTED & DISLOCATED. I&D. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 24165934 ↗
• InjuryDec 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT POLY DISLODGED. NEEDED TO REVISE THE SHELL, POLY AND GLENOSPHERE. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 23692702 ↗
• 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 ENHANCE 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 23545259 ↗
• 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 22977372 ↗
• InjuryAug 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AND INSTABILITY. NO ISSUE WITH POLY, JUST NEEDED A THICKER LINER. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22814431 ↗
• InjuryJul 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT SHOULDER PROSTHETIC JOINT DISLOCATION DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: NOT RELATED PROCEDURE RELATED: CAUSAL RELATIONSHIP DATE OF EVENT: 24 JUN 2025 DATE OF IMPLANT: (B)(6) 2025 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: RESULTED IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION, LABS, IMAGING, ECG, INJECTED MEDICATION (ETOMIDATE, PROPOFOL, FENTANYL, MORPHINE, ONDANSETRON, DIPHENHYDRAMINE, KETOROLAC, MIDAZOLAM), NON-SURGICAL TREATMENTS (SHOULDER REDUCTION UNDER SEDATION), SURGICAL INTERVENTION FOR THE STUDY SHOULDER, NEW COMPONENTS IMPLANTED (HUMERAL POLYETHYLENE +4 MM RETENTIVE).

  Patient problems: Joint Dislocation

  MAUDE report 22518741 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INSTABILITY. THE GLENOSPHERE, SHELL, AND POLY WERE REMOVED AND REPLACED WITH DIFFERENT SIZES. DOI:(B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22332114 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 22053766 ↗
• InjuryApr 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED; CAUSED BY DISLOCATION. DOI: (B)(6) 2024, DOR: (B)(6) 2025 , AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 21921757 ↗
• InjuryMar 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 INHANCE 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 METALOSIS 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 METALOSIS 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 METALOSIS, 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 METALOSIS 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 TRIALED A FEW HUMERAL SHELL AND POLY COMBINATIONS TO DETERMINE WH

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 21551984 ↗
• 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 20820909 ↗
• InjuryOct 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 20343663 ↗
• 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 19940415 ↗
• InjuryJan 29, 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 AND NO ADVERSE CONSEQUENCES.

  Patient problems: Joint Laxity

  MAUDE report 18596658 ↗
• InjuryJan 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 18433938 ↗