INHANCE 5500-25-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295548829), received between Mar 15, 2023 and Sep 22, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that there was an infection. No other information was provided.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50853776 ↗
• 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 25457297 ↗
• 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: (B)(6) 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

  Patient problems: Loss of Range of Motion; Nerve Damage

  MAUDE report 25325227 ↗
• InjuryDec 11, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT LOOSE BASEPLATE WAS REMOVED AND REVISED TO DJO BASEPLATE, WHICH WAS THEN PAIRED WITH A DEPUY STEM. THE EVENT PROMPTED EVALUATION FOR INFECTION. ALL COMPONENTS EXCEPT THE STEM WERE REMOVED, AND THERE WAS NO CASE DELAY. THE IMPLANTS WERE SENT TO PATHOLOGY, DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE- LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 23781133 ↗
• InjuryJul 29, 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: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22644756 ↗
• InjuryJul 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 22621995 ↗
• 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 20662990 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS REVISED ON (B)(6) 2024 DUE TO PROBABLE INFECTION. ORIGINAL IMPLANT DATE WAS (B)(6) 2023

  Patient problems: Unspecified Infection

  MAUDE report 20500657 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS BEING REVISED DUE TO PAIN AND DISCOMFORT IN THEIR SHOULDER. DR INFORMED THAT THE PATIENT FELT A POP FOLLOWED BY PAIN AFTER LIFTING SOMETHING ABOVE THEIR HEAD. DR.¿S PA INFORMED THAT THERE MAY HAVE BEEN A FRACTURE OF THE PATIENTS GLENOID. DR REMOVED THE GLENOID AND HUMERAL COMPONENTS AND OPTED TO REVISE THE PATIENT WITH ZIMMER-BIOMET IMPLANTS. ONCE THE IMPLANTS WERE REMOVED, DR TOLD THE REP THAT HE WOULD BE GOING WITH ZIMMER-BIOMET, AND THAT HE NO LONGER NEEDED REP'S ASSISTANCE IN THE ROOM. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Bone Fracture(s); Discomfort; Pain

  MAUDE report 16544467 ↗