INHANCE 5200-02-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295547099), received between May 26, 2025 and May 12, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF STEM IN SHOULDER. LOOSE STEM WAS REMOVED AND NEW IMPLANT CEMENTED. DOI: UNKNOWN, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 25149263 ↗
• 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 24042734 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SHOULDER WAS INFECTED, SURGEON PULLED COMPONENTS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 24039779 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR GREATER TUBEROSITY FRACTURE DEVICE RELATED: PROBABLE, PROCEDURE RELATED: PROBABLE, DATE OF EVENT: 1 DEC 2025, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: RECOVERING/RESOLVING, SURGICAL INTERVENTION FOR THE STUDY SHOULDER, OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 23833671 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND THE IMPLANTS NEEDED TO BE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22649770 ↗
• 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 22283579 ↗
• MalfunctionMay 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A LEFT REVERSE TSA. WHEN THE STEM WAS OPENED, IT WAS NOTED THE SEALED STICKER WAS BROKEN AND HAD PREVIOUSLY BEEN OPENED; THERE WAS ALSO A HOLE IN THE STERILE PACKAGING. IT WAS DECIDED TO NOT USE THAT STEM. THERE WAS A SHORT SURGICAL DELAY WHILE ANOTHER STEM WAS RETRIEVED. A SMALLER SIZE WAS USED WITH NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084511 ↗