INHANCE 5500-40-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295546825), received between Dec 1, 2023 and May 18, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED AND WAS REVISED TO A RETENTIVE POLY. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2026, AFFECTED SIDE-UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 25200981 ↗
• InjuryMay 1, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT COMES IN TODAY HAVING PROBLEMS WITH CHRONIC DISLOCATIONS. THE PATIENT LIFTED A HEAVY BOX 4 WEEKS POST OP AND DISLOCATED CAUSING MORE PROBLEMS. THE DOCTOR DECIDED IT BEST TO REMOVE HIS GLENOSPHERE AND POLY TO REBALANCE THE SHOULDER. WHILE DOING THIS THE PROXIMAL HUMERUS FRACTURED SO HE REMOVED THE STEM AND SHELL AS WELL. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 25056064 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NEED MORE STABILITY. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 25001950 ↗
• 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 24427821 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(6). 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 24042698 ↗
• 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 22645092 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ENHANCE REVERSE TOTAL SHOULDER WAS UNSTABLE WITH TOO MUCH LAXITY TO FUNCTION PROPERLY. HUMERAL HEAD AND HUMERAL LINER WERE REMOVED AND UPSIZED TO CREATE MORE STABILITY IN THE GLENOHUMERAL JOINT. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22507890 ↗
• InjuryDec 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 20867548 ↗
• InjuryMar 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD SHOULDER DISLOCATION APPROX 8 WEEKS POST-OP. SURGEON REVISED THE JOINT DUE TO INSTABILITY. THERE WAS NO DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 18902471 ↗
• InjuryDec 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S SHOULDER WAS DISLOCATED, IT WAS UNSURE HOW IT WAS DISLOCATED. THE SHELL AND LINER WERE SWAPPED FOR A NEW SHELL AND RETENTIVE LINER. UNKNOWN SURGICAL DELAY. NOTHING FURTHER TO REPORT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 18246810 ↗