INHANCE 5505-32-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295546672), received between Nov 2, 2023 and Feb 13, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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.

• 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 24333750 ↗
• 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)(4). 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

  Patient problems: Pain

  MAUDE report 23768889 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: TREATMENT/IMPACT: REHABILITATION, INJECTED MEDICATION (SPECIFY: 2 ML OF 1% LIDOCAINE 2 ML OF 0.25% MARCAINE AND 2 ML OF BETAMETHASONE) AND ORAL/TOPICAL MEDICATION (SPECIFY: MEDROL DOSEPAK), OUTCOME: RECOVERING/RESOLVING.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23287059 ↗
• InjuryAug 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S ORIGINAL SURGERY DATE WAS (B)(6) 2025. PATIENT WAS NON-COMPLIANT. SURGEON WAS REMOVING ITS SLING BEFORE RELEASED TO DO SO, AND DISLOCATED. DUE TO THIS THE SURGEON BROUGHT THE PATIENT BACK FOR A REVISION TO INCREASE THE SIZE OF THE GLENOSPHERE. THE REVERSE SHELL, AND POLY LINER WERE REMOVED TO GAIN ACCESS TO THE GLENOID. THE 32+8 WAS REMOVED AND REPLACED WITH A 36+8. THERE WERE NO ALLEGATIONS MADE AGAINST THE PRODUCT, AND THE CASE WENT WITHOUT INCIDENT. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22841842 ↗
• 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 22665704 ↗
• 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 22056780 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD THEIR INITIAL SURGERY ON (B)(6) 2024. PATIENT WAS COMPLAINING OF SOME IMPINGEMENT OF THEIR SHOULDER. DOCTOR REVISED THE SHOULDER AND CHANGED THE GLENOSPHERE FROM A 32+8 TO A 36+4 ECCENTRIC. THE ECCENTRICITY WAS THEN POSITIONED POSTERIOR. A TRIAL REDUCTION WAS PERFORMED WITH A 36+0 POLY AND THE PATIENTS RANGE OF MOTION APPEARED TO IMPROVE. DOCTOR DECIDED THAT GOING WITH A 36+0 RETENTIVE POLY WOULD PROVIDE A LITTLE ADDITIONAL STABILITY, SO THAT POLY WAS OPENED AND IMPLANTED. THE SHOULDER WAS REDUCED AND STABILITY WAS CONFIRMED. THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. 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 21405914 ↗
• InjuryDec 2, 2024Adverse 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. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 20823530 ↗
• 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 19513060 ↗
• InjuryMar 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR A POST OP CHECKUP WITH SOME SHOULDER SORENESS. UNFORTUNATELY HER SHOULDER HAD BECOME DISLOCATED. A CLOSED REDUCTION WAS PERFORMED AND SHE DISLOCATED AGAIN. THE SURGEON FELT THE PATIENT WOULD BENEFIT FROM A EXCHANGE OF THE GLENOSPHERE AND HUMERAL SHELL/POLY. THE 32 GLENOSPHERE WAS REMOVED AND A 36 WAS IMPLANTED. A TRIAL REDUCTION WAS PERFORMED WITH A +0 METAL SHELL AND +0 RETENTIVE POLY. STABILITY WAS CONFIRMED AND THE REAL IMPLANTS WERE OPENED AND INSERTED. THERE WERE NO SURGICAL DELAYS OR ADVERSE EVENTS TOOK PLACE. THE CLOSING PROCESS BEGAN. DOI: (B)(6), 2024; DOR: (B)(6), 2024; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity; Pain

  MAUDE report 18956428 ↗
• InjuryDec 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SURGEON BELIEVES THE PATIENT WAS NON COMPLIANT AS HE WAS NOT USING HIS SLING, AND ALSO HAD AN ABRASION ON HIS ELBOW CONSISTENT WITH A FALL HOWEVER HE WOULD NOT ADMIT TO FALLING DOWN AND THAT BEING THE CAUSE OF THE DISLOCATION. DOI: 16 OCT 2023 DOR: 28 NOV 2023 AFFECTED SIDE : RIGHT SHOULDER

  Patient problems: Joint Dislocation

  MAUDE report 18274119 ↗
• MalfunctionNov 2, 2023Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? -THERE WAS SLIGHT SURGICAL DELAY 5-10 MINUTES. B. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? -THERE WAS NO ADVERSE IMPACT ON PATIENT. C. DID IT BREAK INTO TWO OR MORE PIECES? IF YES, WERE ALL THE FRAGMENTS RETRIEVED FROM THE PATIENT? -THE GLENOSPEHERE WAS NOT FRAGMENTED AND LOOKS TO BE INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18060075 ↗