INHANCE 5500-00-408Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295546979), received between Oct 5, 2023 and Sep 3, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

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

  Subject ID: (b)(6)Study No: DSM202108 Clinical Adverse Event received for Numbness in Fingers following peripheral nerve blockDevice Related: Not Related Procedure Related: PossibleDate of Event: (b)(6) 2026Date of Implant: (b)(6) 2026Date of Revision: No Information ProvidedDevice Location: Left Treatment/Impact: Observation DePuy Synthes Products Used: Catalog Number: 550515290Lot Number: 666230Type: BASEPLATEDescription: INHANCE SHOULDER SYSTEM R/SPEED UNITI PLATFORM BASEPLATE LARGE Ø29mm CEMENTLESSCatalog Number: 550300500Lot Number: 240761Type: SCREWDescription: INHANCE SHOULDER SYSTEM SELF-DRILLING & LOCKING SCREW 4 PACK 20mm & 25mmCatalog Number: 550540004Lot Number: 357663Type: GLENOSPHEREDescription: INHANCE SHOULDER SYSTEM GLENOSPHERE Ø40+4mmCatalog Number: 520000040Lot Number: 6642881Type: HUMERALDescription: INHANCE SHOULDER SYSTEM STEMLESS LARGE DIAMETER 40mm CEMENTLESSCatalog Number: 550000408Lot Number: 659079Type: SHELLDescription: INHANCE SHOULDER SYSTEM REVERSE HUMERAL SHELL LARGE Ø40+8mmCatalog Number: 550040000Lot Number: MI134856Type: LINERDescription: INHANCE SHOULDER SYSTEM REVERSE LINER X-LINKED VITAMIN E PE Ø40+0mm

  Patient problems: Nerve Damage; Numbness

  MAUDE report 50589672 ↗
• 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 24333754 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS NOT STABLE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23991197 ↗
• InjuryDec 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT POLY DISLODGED. NEEDED TO REVISE THE SHELL, POLY AND GLENOSPHERE. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 23692667 ↗
• InjuryJun 18, 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: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22283779 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR POSSIBLE INFECTION. LINER AND SHELL REMOVED AND REPLACED. THE SURGICAL DELAY IS UNKNOWN. THERE WAS NO SURGICAL DELAY AND ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21258227 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT'S SOFT TISSUE STRUCTURES WERE LOOSE AND THEREFORE THE SURGEON NEEDED TO REVISE TO LARGER COMPONENTS. THERE WAS NO SURGICAL DELAY NOR ANY HARM TO THE PATIENT.

  Patient problems: Joint Laxity

  MAUDE report 20181089 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISLOCATION FROM INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 19485393 ↗
• InjuryDec 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S SHOULDER WAS DISLOCATED, IT WAS UNSURE HOW IT WAS DISLOCATED. THE SHELL AND LINER WERE SWAPPED FOR A NEW SHELL AND RETENTIVE LINER. UNKNOWN SURGICAL DELAY. NOTHING FURTHER TO REPORT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 18246798 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXCHANGE OF IMPLANTS WAS PERFORMED DURING I&D DUE TO CONFIRMED INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17875803 ↗