INHANCE 5500-32-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295546740), received between Jun 11, 2024 and Aug 3, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  Subject ID: (b)(6).Study No: (b)(4).Clinical Adverse Event received for closed nondisplaced fracture of acromial process of right scapula:Device Related: Not related,Procedure Related: Probable,Date of Event: 25 Jul 2025,Date of Implant: on (b)(6) 2025,Date of Revision: No information provided,Device Location: Right.Treatment/Impact: Other non-surgical treatments: Yes (Specify: sling with abduction pillow, CT scan with metal artifact reduction,Components removed :Humeral Stemless Implant: Yes, Reverse Humeral Shell: Yes, Reverse Liner: Yes, Glenosphere: Yes.Diagnostic intervention: (Specify: CT scan with metal artifact reduction), Other non-surgical treatments (Specify: sling with abduction pillow).Resulted in medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function: YES.Surgical intervention for the study shoulder: YES.Staged revision: YES.DePuy Synthes Products Used:Catalog Number: 520000040,Lot Number: 662039,Component Type: HUMERAL,Description: INHANCE SHOULDER SYSTEM STEMLESS LARGE DIAMETER 40mm CEMENTLESS,Catalog Number: 550000400,Lot Number: 664523,Component Type: SHELL,Description: INHANCE

  Patient problems: Bone Fracture(s)

  MAUDE report 50121933 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ASEPTIC REVISION FOR INSTABILITY FROM HETEROTOPIC OSSIFICATION. THE SURGEON REVISED GLENOSPHERE FROM 32+4 TO 36+8 AND CHANGED SHELL LARGE 0 AND LINER TO 36+4 RETENTIVE. REMOVED THE HO AND SHOULDER WAS FREE OF IMPINGEMENT. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Extraskeletal ossification; Joint Laxity

  MAUDE report 24800955 ↗
• InjuryApr 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD SHOULDER DONE ON AN UNKNOWN DATE. POSTOPERATIVELY THE PATIENT SUFFERED A SHOULDER DISLOCATION. SURGEON OPTED TO CHANGE THE GLENOSPHERE, HUMERAL SHELL, AND POLYETHYLENE TO FURTHER TENSION THE SHOULDER JOINT. TRIAL REDUCTIONS WERE PERFORMED AND STABILITY WAS CONFIRMED WITH A 40+8 GLENOSPHERE, +0 HUMERAL SHELL, AND NEW POLYETHYLENE. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. CLOSING PROCESS BEGAN. ACTIVITY LEVEL - YES. DOI: UNKNOWN, DOR: ON (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 24793101 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOCTOR UPSIZED THE GLENOSPHERE AND HUMERAL COMPONENTS. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 24333730 ↗
• InjuryDec 10, 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 WORSENING BILATERAL SHOULDER PAIN DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: POSSIBLE. DATE OF EVENT: 19 NOV 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REHABILITATION, INJECTED MEDICATION (TRIAMCINOLONE (KENALOG-40) INJECTION 20-120 MG). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 520000040. LOT NUMBER: 662039. COMPONENT TYPE: HUMERAL. DESCRIPTION: INHANCE SHOULDER SYSTEM STEMLESS LARGE DIAMETER 40MM CEMENTLESS. CATALOG NUMBER: 550011240. LOT NUMBER: 663949. COMPONENT TYPE: BASEPLATE. DESCRIPTION: INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS. CATALOG NUMBER: 550300500. LOT NUMBER: 220085. COMPONENT TYPE: SCREW. DESCRIPTION: INHANCE SHOULDER SYSTEM SELF-DRILLING & LOCKING SCREW 4 PACK 20MM & 25MM. CATALOG NUMBER: 550035600. LOT NUMBER: 217704. COMPONENT TYPE: SCREW. DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM. CATALOG NUMBER: 550532008. LOT NUMBER: 345531. COMPONENT TYPE: GLENOSPHERE. DESCRIPTION: INHANCE SHOULDER SYSTEM GLENOSPHERE Ø32+8MM. CATALOG NUMBER: 550000400. LOT NU

  Patient problems: Pain

  MAUDE report 23767938 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UNSTABLE SHOULDER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23605944 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WASN¿T HAPPY WITH THE RESULTS, SO THE DOCTOR DID A PLOY GLENOSPHERE EXCHANGE FOR MORE STABILITY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22908931 ↗
• InjuryJul 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AND PATIENT INSTABILITY, SO SURGEON HAD TO TAKE OUT IMPLANTS AND PUT IN MORE STABLE OPTION. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22665702 ↗
• InjuryMay 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22056781 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE 16MM CANNULATED FLEXIBLE DRILL BIT, HAD RUST INSIDE CANNULA AND 16 CANN PERCUTANEOUS FLEXIBLE DRILL BIT, TIP IS CHIPPED. THERE WAS NO OPERATION INVOLVED AND NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. ACTIVITY LEVEL - YES. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 21406813 ↗
• InjuryFeb 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATED LEFT REVERSE SHOULDER. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 21326301 ↗
• InjuryJun 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO UNSTABLE AND DISLOCATED SHOULDER. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 19513041 ↗