INHANCE 5503-10-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295546580), received between Apr 25, 2023 and Sep 15, 2026 — classified as 14 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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 50771718 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that all Inhance reverse implants were explanted due to infection.DOI: (b)(6), 2026DOR: (b)(6), 2026

  Patient problems: Unspecified Infection

  MAUDE report 50751550 ↗
• MalfunctionSep 2, 2026Difficult to Insert; Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568212 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 24568311 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 24568276 ↗
• MalfunctionFeb 11, 2026Migration

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR IMPLANT SHIFT. DEVICE RELATED: CASUAL RELATIONSHIP (HUMERAL STEMLESS IMPLANT: YES). PROCEDURE RELATED: POSSIBLE. DATE OF EVENT: 26 JAN 2026. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: OBSERVATION. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550011240. LOT NUMBER: 66451. COMPONENT TYPE: BASEPLATE. DESCRIPTION: INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS. CATALOG NUMBER: 550035600. LOT NUMBER: 237381. COMPONENT TYPE: SCREW. DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM. CATALOG NUMBER: 550310035. LOT NUMBER: 229426. COMPONENT TYPE: SCREW. DESCRIPTION: INHANCE SHOULDER SYSTEM LOCKING SCREW 35MM. CATALOG NUMBER: 550310025. LOT NUMBER: 233600. COMPONENT TYPE: SCREW. DESCRIPTION: INHANCE SHOULDER SYSTEM LOCKING SCREW 25MM. CATALOG NUMBER: 550310035. LOT NUMBER: 223956. COMPONENT TYPE: SCREW. DESCRIPTION: INHANCE SHOULDER SYSTEM LOCKING SCREW 35MM. CATALOG NUMBER: 550540008. LOT NUMBER: 333136. COMPONENT TYPE: GLENOSPHERE. DESCRIPTION: INHANCE SHOULDER SYSTEM GLENOSPHERE Ø40+8MM. CATALOG NUMB

  Patient problems: Insufficient Information

  MAUDE report 24313151 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVERSED TOTAL SHOULDER REVISION OCCURRED DUE TO GLENOSPHERE AND LINER IMPINGEMENT. PATIENT WAS CONVERTED TO HEMI ARTHOPLASTY. DURING THE PROCEDURE THE HEAD TRIAL WAS DAMAGED WHERE THE ADAPTOR FOR HEAD AND TRIAL MEET. THE ATTACHMENT TABS BROKE OFF. THERE WAS NO HARM TO PATIENT AND NO SURGICAL DELAY. DOE: (B)(6) 2026, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 24187935 ↗
• 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 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 24042680 ↗
• MalfunctionNov 26, 2025Fracture; Fracture

  PATIENT WAS REVISED DUE TO 25MM INHANCE LOCKING SCREW BROKE DURING INSERTION. STANDARD PROCEDURE WAS APPLIED WHEN INSERTING SCREW AND SCREW HEAD SNAPPED OFF OF SCREW SHAFT. CASE WAS DELAYED 5 MINUTES DUE TO OCCURRENCE. NO OTHER INFO IS KNOWN. DOE: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655864 ↗
• MalfunctionNov 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE 25 MM INHANCE LOCKING SCREW BROKE DURING INSERTION. STANDARD PROCEDURE WAS APPLIED WHEN INSERTING SCREW AND SCREW HEAD SNAPPED OFF OF SCREW SHAFT. CASE WAS DELAYED 5 MINUTES DUE TO OCCURRENCE.

  Patient problems: Insufficient Information

  MAUDE report 23597174 ↗
• 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 22615766 ↗
• InjuryJul 24, 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: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22594491 ↗
• InjuryJul 24, 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: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22594445 ↗
• InjuryJul 16, 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 INFECTION. ALL COMPONENTS WERE TAKEN OUT. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22522967 ↗
• MalfunctionMay 28, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PERIPHERAL LOCKING SCREW WENT THROUGH BASEPLATE WHEN THREADING IN. THE SURGEON EXPLANTED THAT SAME SCREW AND IMPLANTED A NEW ONE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099930 ↗
• MalfunctionMay 13, 2025Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE 25MM LOCKING SCREW WAS DEFECTIVE. THE HEAD OF THE SCREW PASSED THROUGH THE BASEPLATE WITHOUT LOCKING INTO THE BASEPLATE. THE SURGICAL DELAY IS UNKNOWN. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 22009615 ↗
• InjuryNov 12, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE GLENOID COMPONENT FAILED. THERE WAS LOOSENING OF THE GLENOSPHERE AND BASEPLATE. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20663140 ↗
• InjuryNov 12, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE GLENOID COMPONENT FAILED. THERE WAS LOOSENING OF THE GLENOSPHERE AND BASEPLATE. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20663111 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIS RIGHT SHOULDER REPLACED BY THE PRIMARY SURGEON ON (B)(6) 2022 WHERE HE RECEIVED A DELTA EXTEND REVERSE SHOULDER CONSTRUCT. HE CAME TO THE REVISING SURGEON EARLIER THIS YEAR WITH SHOULDER PAIN WHERE THE SURGEON REVISED THE CONSTRUCT BECAUSE OF A LOOSE BASEPLATE. UNFORTUNATELY, THE PATIENT SHOULDER BECAME INFECTED FOLLOWING THE REVISION. THE REVISING SURGEON THEN REVISED THE SHOULDER AND EXPLANTED ALL OF THE COMPONENTS AND IMPLANTED A ANTIBIOTIC SPACER. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 19710806 ↗
• MalfunctionJan 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE 25MM LOCKING SCREW BROKE WHILE BEING INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503464 ↗
• 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. NO OTHER INFORMATION IS KNOWN. DOI: (B)(6) 2023; DOE: (B)(6) 2023; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17297787 ↗
• MalfunctionApr 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT WHILE INSERTING ONE OF THE GLENOID LOCKING SCREWS A SCREW HEAD WAS BROKEN OFF. THE SCREW WHICH WAS A 25MM LOCKING SCREW AND WAS THE ANTERIOR SCREW IN THE GLENOID BASEPLATE. THE SCREW WAS RECESSED BENEATH THE BASEPLATE AND WAS SUBSEQUENTLY LEFT IN THE PATIENT AND IS NOT EXPECTED TO CAUSE ANY ISSUES FOR THE PATIENT MOVING FORWARD. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811254 ↗