INHANCE 5505-36-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10603295546689), received between Jan 6, 2023 and Sep 30, 2026 — classified as 51 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (19 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

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

  It was reported that the revised was performed due to instability following a post op fracture causing the stem to loosen and it was stated that the humeral stem was loose and at the bone to implant interface.DOI-(b)(6)2026.DOR-(b)(6)2026.Affected side-Right.

  Patient problems: Joint Laxity

  MAUDE report 50944844 ↗
• InjurySep 29, 2026Device Dislodged or Dislocated

  It was reported that Glenoshpere disengaged from baseplate. Revision surgery removed poly and glenosphere and replaced with new components.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected Side: Right Shoulder.

  Patient problems: Insufficient Information

  MAUDE report 50933182 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Muscular Rigidity

  MAUDE report 50823076 ↗
• InjurySep 16, 2026Device Dislodged or Dislocated

  It was reported that the shoulder revised due to disassociated glenosphere. Stem was in varus position & explanted. During extraction, the shell / taper adapter became stuck on the star drive 30. The reporter were not able to get them separated. The glenosphere was not "lose at the bone to implant interface", the glenosphere was disassociated from the baseplate. There was no issue with the reverse liner. DOI: (b)(6) 2023DOR: (b)(6) 2026Affected side: Right(b)(4) and (b)(4) are related.(b)(4) for the revision surgery due to disassociated.(b)(4) for during extraction, the shell / taper adapter became stuck on the star drive 30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789982 ↗
• InjurySep 14, 2026Device Dislodged or Dislocated

  It was reported that the patient dislocated. Affected side: Unknown shoulder.

  Patient problems: Joint Dislocation

  MAUDE report 50754407 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the revision and washout was completed due to surgeon suspicion of infection. The glenosphere and poly liner were exchanged during the washout. The original surgery was completed by the doctor on (b)(6)26. There was no other information was known.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Left Shoulder.

  Patient problems: Unspecified Infection

  MAUDE report 50712779 ↗
• InjurySep 2, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 50573178 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR PAIN. DOI-UNKNOWN DOR-(B)(6) 2026 AFFECTED SIDE-UNKNOWN.

  Patient problems: Pain

  MAUDE report 25457345 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: DATE OF REVISION WAS (B)(6) 2026. PRIMARY SURGERY WAS (B)(6). UNKNOWN ON ALERT DATE. SOMETIME BETWEEN 4/25 AND 4/28. PT WAS TAKEN BACK TO SURGERY DUE TO THE TIGHTNESS. IT WAS NOT UNSTABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 25127658 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 24800304 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED THE PATIENT EXPERIENCED PERSISTENT INSTABILITY IN THE LEFT SHOULDER FOLLOWING A REVERSE TOTAL SHOULDER ARTHROPLASTY, DESPITE INITIAL POSTOPERATIVE IMPROVEMENT. IMAGING CONFIRMED STABLE ALIGNMENT OF THE IMPLANT, AND THE INSTABILITY DID NOT RESULT IN A TRUE GLENOHUMERAL DISLOCATION. PERSISTENT SYMPTOMS LED TO A DIAGNOSTIC CT SCAN TO ASSESS PROSTHESIS STABILITY AND POSITION. DEVICE RELATED: POSSIBLE (HUMERAL STEMLESS IMPLANT: YES); PROCEDURE RELATED: POSSIBLE; DATE OF EVENT: (B)(6) 2026; DATE OF IMPLANT: (B)(6) 2025; DATE OF REVISION: NO INFORMATION PROVIDED; DEVICE LOCATION: LEFT. TREATMENT/IMPACT: DIAGNOSTIC INTERVENTION (CT). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 520000036; LOT NUMBER: 662988; COMPONENT TYPE: HUMERAL; DESCRIPTION: INHANCE SHOULDER SYSTEM STEMLESS MEDIUM DIAMETER 36MM CEMENTLESS. CATALOG NUMBER: 550011240; LOT NUMBER: 664496; COMPONENT TYPE: : BASEPLATE; DESCRIPTION: INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS. CATALOG NUMBER: 550035600; LOT NUMBER: 206439; COMPONENT TYPE: SCREW; DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM. CATALOG NUMB

  Patient problems: Joint Laxity; Pain

  MAUDE report 24616348 ↗
• 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 24568366 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO LACK OF MOTION, WHICH INCLUDED SCAR EXCISION AND EXCHANGE OF THE GLENOSPHERE AND LINER. ALL COMPONENTS WERE NOTED TO BE WELL FIXED AT THE TIME OF REVISION. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 24251683 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NO INFORMATION PROVIDED, PROCEDURE RELATED: NO INFORMATION PROVIDED, DATE OF EVENT: 8 JAN 2026, DATE OF IMPLANT: ON (B)(6) 2025, DATE OF REVISION: ON (B)(6) 2026, DEVICE LOCATION: RIGHT, TREATMENT/IMPACT: COMPONENTS REMOVED (CUP), DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550011240, LOT NUMBER: 664514, COMPONENT TYPE: BASEPLATE, DESCRIPTION: MODULAR UNITI PLATFORM BASEPLATE S 24, CATALOG NUMBER: 550030600, LOT NUMBER: 227541, COMPONENT TYPE: SCREW, DESCRIPTION: INHANCE CENTRAL SCREW 6.0X30, CATALOG NUMBER: 550300500, LOT NUMBER: 235418, COMPONENT TYPE: SCREW, DESCRIPTION: INHANCE 4PK LOCKING SCRW 2025 SLFDRILL, CATALOG NUMBER: 550536004, LOT NUMBER: 350285, COMPONENT TYPE: GLENOID, DESCRIPTION: INHANCE GLENOSPHERE 36+4, CATALOG NUMBER: 520001040, LOT NUMBER: 664294, COMPONENT TYPE: STEM, DESCRIPTION: INHANCE SHORT STEM L 40, CATALOG NUMBER: 550000400, LOT NUMBER: 664524, COMPONENT TYPE: SHELL, DESCRIPTION: INHANCE REVERSE HUMERAL SHELL L 40+0, CATALOG NUMBER: 550036104, LOT NUMBER: MI125080, COMPONENT TYPE: LINER, DESCRIPTION: INHANC

  Patient problems: Unspecified Infection

  MAUDE report 24233023 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24221758 ↗
• 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 24039504 ↗
• MalfunctionJan 7, 2026Difficult to Insert

  IT WAS REPORTED THAT GLENOSPHERE TAPER WOULD NOT ENGAGE R-SPEED BASEPLATE. DOE: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991403 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23934484 ↗
• InjuryDec 15, 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. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23803389 ↗
• InjuryDec 9, 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. INCREASED GLENO AND ADDED RETENTIVE POLY. NO LOOSENING OR IMPLANT FAILURE. NO CASE DELAY. NO BROKEN PIECES. ALL PIECES WERE REMOVED. NO OTHER INFORMATION KNOWN. DOI (B)(6) 2025, DOR (B)(6) 2025, AFFECTED SIDE-RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23761239 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGEON DECIDED INTRAOP TO INCREASE GLENOSPHERE SIZE. THERE WAS NO COMPLAINT OR LOOSENING. NO DELAY. NO BROKEN PIECES, NOTHING LEFT BEHIND. NOT SURE OF ORIGINAL IMPLANTATION DATE. NO OTHER INFORMATION KNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 23744105 ↗
• InjuryNov 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY, NO IMPLANT FAILURE. UPON EXTRACTION OF GLENOSPHERE THE SET SCREW WAS RETAINED IN THE BASEPLATE, STRIPPED UNABLE TO USE STAR 20. REMOVED WITH BROKEN SCREW SET. NO OTHER INFORMATION KNOWN. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23603843 ↗
• InjuryNov 12, 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: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23537027 ↗
• MalfunctionNov 12, 2025Difficult to Insert; Difficult to Insert

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION ON THE LEFT SHOULDER DUE TO THE GLENOSPHERE NOT ARTICULATING WITH THE BASEPLATE AND WITH THREADING UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535034 ↗
• InjuryNov 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL SURGERY AS GLENOSPHERE WAS NOT LOCKED INTO BASEPLATE.

  Patient problems: Insufficient Information

  MAUDE report 23517558 ↗