INHANCE 5503-10-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295546566), received between Jul 11, 2023 and Sep 22, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that infection. No other information was provided.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50853844 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revision due to infection/fracture from fall.DOI: (b)(6) 2025.DOR: (b)(6) 2026.Affected Side: Right.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 50772072 ↗
• 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 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 24042677 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24039370 ↗
• InjuryDec 3, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT SURGEON REVISED THE GLENOSPHERE AND HUMERAL SHELL DUE TO INSTABILITY AND A DISLODGED SCREW. ALL PIECES WERE REMOVED FROM THE PATIENT. THERE WAS NO DELAY TO THE CASE. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 23709911 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT AN INHANCE REVERSE TOTAL IN (B)(6) OF 2025. IT WAS SUSPECTED THAT THE INITIAL TENSION OF THE ORIGINAL WAS TOO LOOSE. REVISED TO A THICKER POLY CONSTRUCT, BIGGER AND MORE LATERALIZED GLENOSPHERE. DOI: (B)(6) 2025, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23545202 ↗
• InjuryJul 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT COMPONENTS WERE REMOVED DUE TO LOCKING SCREW BEING BROKEN & INFECTION OF THE JOINT. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22615762 ↗
• InjuryJun 6, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVERSE TOTAL SHOULDER DONE IN APRIL. THE BASE PLATE PULLED OUT OF THE GLENOID SHORTLY THEREAFTER DUE TO INCREDIBLY POOR BONE STOCK. THERE WAS NON-CEMENTED LOOSENING OF THE BASEPLATE. SURGEON REMOVED THE BASEPLATE AND CONVERTED TO A HEMI. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22160628 ↗
• InjuryJun 6, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVERSE TOTAL SHOULDER DONE IN (B)(6). THE BASE PLATE PULLED OUT OF THE GLENOID SHORTLY THEREAFTER DUE TO INCREDIBLY POOR BONE STOCK. THERE WAS NON-CEMENTED LOOSENING OF THE BASEPLATE. SURGEON REMOVED THE BASEPLATE AND CONVERTED TO A HEMI. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22160593 ↗
• InjuryNov 11, 2024Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO SURGICAL DELAY. B. WHAT WAS THE REASON FOR REPLACING THE GLENOSPHERE AND THE CUP? HAD TO REMOVE TO GET SCREWS OUT AND PUT NEW IMPLANTS IN.

  Patient problems: Pain

  MAUDE report 20653804 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS REVISED ON (B)(6) 2024 DUE TO PROBABLE INFECTION. ORIGINAL IMPLANT DATE WAS (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 20502346 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS REVISED ON (B)(6) 2024 DUE TO PROBABLE INFECTION. ORIGINAL IMPLANT DATE WAS (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 20498119 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WAS SUSPICION OF INFECTION. IT IS UNKNOWN IF INFECTION WAS PRESENT. IMPLANTS WERE REMOVED. IT WAS THEN WASHED OUT AND NEW IMPLANTS WERE INSERTED. N. DOI: (B)(6) 2023; DOE: (B)(6)2023; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17297795 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WAS SUSPICION OF INFECTION. IT IS UNKNOWN IF INFECTION WAS PRESENT. IMPLANTS WERE REMOVED. IT WAS THEN WASHED OUT AND NEW IMPLANTS WERE INSERTED. DOI: (B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17297783 ↗