INHANCE 5500-36-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295546788), received between Jan 18, 2024 and Sep 16, 2026 — classified as 22 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to impingement/infection. The surgeon performed washout and reimplantation of prosthesis. DOI: On (b)(6) 2024.DOR: On (b)(6) 2026.Affected Side: Right Shoulder.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 50791419 ↗
• InjurySep 16, 2026Device Dislodged or Dislocated

  It was reported that patient suffered a dislocation of their shoulder post-operatively. The doctor felt the patient would benefit from a shoulder revision where we upsized the numeral poly thickness or glenosphere components. The +0 Humeral shell and +0 Retentive poly was removed. A trial reduction was performed with a +8 humeral shell and +0 retentive poly. The shoulder was found the be stable. The real implants were opened and implanted. Stability was confirmed when reducing the shoulder and the closing process began. No delays or adverse events took place.Affected side: Right shoulder.

  Patient problems: Joint Dislocation

  MAUDE report 50785981 ↗
• InjurySep 14, 2026Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 50754502 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR POOR ACTIVE MOTION, POSSIBLE AXILLARY NERVE INJURY DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NOT RELATED PROCEDURE RELATED: POSSIBLE DATE OF EVENT: 4 FEB 2026 DATE OF IMPLANT: (B)(6) 2026 DATE OF REVISION: NO INTERVENTION PROVIDED DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: DIAGNOSTIC INTERVENTION: YES SPECIFY: NCV/EMG. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550036100 LOT NUMBER: MI191184 COMPONENT TYPE: LINER UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550310015 LOT NUMBER: 230230 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550000360 LOT NUMBER: 661634 COMPONENT TYPE: SHELL UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550536104 LOT NUMBER: 351208 COMPONENT TYPE: GLENOSPHERE UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 520000036 LOT NUMBER: 662988 COMPONENT TYPE: HUMERAL UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550310030 LOT NUMBER: 239924 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550310020 LOT NUMBER: 219917 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550025600 LOT NUMBER: 234397 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER:

  Patient problems: Loss of Range of Motion; Nerve Damage

  MAUDE report 25322817 ↗
• 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 (B)(6) AND (B)(6). PT WAS TAKEN BACK TO SURGERY DUE TO THE TIGHTNESS. IT WAS NOT UNSTABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 25126125 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24924579 ↗
• InjuryMar 25, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION POLY/GLENO WAS SWAP. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 24691482 ↗
• 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 24616396 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT I/D POLY AND GLENO SWAP. DOI-UNKNOWN, DOR- (B)(6) 2026, AFFECTED SIDE-RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 24491497 ↗
• 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 24251685 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (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 23934539 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO WASHOUT FOR INFECTION. THE DOCTOR DECIDED TO CHANGE THE STEM TO PUT IT IN A BETTER POSITION WHILE HE WAS IN THIS PROCEDURE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 23730823 ↗
• 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 23537002 ↗
• InjuryAug 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THE SURGEON DECIDED TO REVISE TO A THICKER POLY AND MORE LATERALIZED GLENOSPHERE. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22907278 ↗
• InjuryAug 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING AND NEEDED TO TIGHT UP THE GAB. DOI: UNKNOWN DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22845759 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 21654260 ↗
• MalfunctionJan 27, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT ANATOMIC HEAD, OFFSET TAPER ADAPTOR AND ANATOMIC HYBRID GLENOID WERE EXPLANTED DUE TO SUBSCAPULARIS FAILURE AND THE CONSTRUCT WAS CONVERTED TO REVERSE TOTAL SHOULDER. IN ADDITION TO THIS, A 36 +0 RETENTIVE LINER WOULD NOT LOCK INTO THE REVERSE HUMERAL SHELL PROPERLY AND WAS WASTED DURING THE PROCEDURE. NO ADVERSE CONSEQUENCES FOR THE PATIENT OCCURRED. THERE WAS NO SURGICAL DELAY AND THE LINER ISSUE OCCURRED INTRA-OP. THE AFFECTED SIDE WAS THE RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246110 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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 20653777 ↗
• InjuryOct 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT GLENOSPHERE AND POLY EXCHANGE FOR HEMATOMA AND ACUTE DISLOCATION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Hematoma; Joint Dislocation

  MAUDE report 20411877 ↗
• InjuryJun 24, 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 19594711 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING - A. THERE WAS NO DELAY. B. RIGHT SIDE. C. PRIMARY PROCEDURE WAS DONE ON (B)(6) 2024. D. THE FIRST WASH OUT WAS ON (B)(6) 2024-THIS PATIENT DID HAVE A WASHOUT/ REVISION ON (B)(6) 2024 DUE TO AN INFECTION, AND NOTHING TO DO WITH THE PRODUCT.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 19527386 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AND NEEDED A WASHOUT AND POLY SWAP. HER ORIGINAL SURGERY WAS ON (B)(6) 2024. THE SURGEON WASHED OUT THIS PATIENT AND REPLACED THE POLY WITH A NEW ONE. HE ALSO DECIDED THAT SHE SEEMED TOO LOOSE AND DECIDED TO SWAP THE +0 SHELL FOR A +8 SHELL. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 19321525 ↗
• InjuryApr 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. PATIENT HAD ORIGINAL SURGERY DONE AT HOSPITAL ON (B)(6) 2024. UNFORTUNATELY THEY DISLOCATED AND NEEDED TO BE REVISED. SURGEON REMOVED THE POLY, SHELL, AND GLENOSPHERE. A BIGGER GLENOSPHERE WAS IMPLANTED TO INCREASE STABILITY. THERE WAS NO ADVERSE EVENTS OR DELAYS TOOK PLACE. DOI: (B)(6) 2024; DOR: UNKNOWN; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 19212964 ↗
• MalfunctionJan 18, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT POLYS WOULD NOT FIT. THE PRODUCT WERE DEFECTIVE. DOE: (B)(6) 2024. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18534891 ↗