INHANCE 5500-00-368Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295546993), received between Apr 22, 2024 and Feb 19, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR JOINT EFFUSION (POSSIBLE INFECTION OF RIGHT SHOULDER INCISION. PT CALLED OFFICE ON (B)(6) STATES HE WAS ADMITTED TO HOSPITAL IN FLORIDA ON (B)(6) ON IV ANTIBIOTICS) NO RELATIONSHIP TO STUDY DEVICE: NOT RELATED RELATIONSHIP TO PRIMARY STUDY PROCEDURE: POSSIBLE DATE OF EVENT: 29 DEC 2025 DATE OF IMPLANT: (B)(6) 2025 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT TREATMENT/IMPACT: HOSPITALIZATIONS, DIAGNOSTIC INTERVENTIONS (VNOUS DUPLEX, ULTRASOUND, MRI, XRAY), INJECTED MEDICATIONS (VANCOMYCIN IVPB 2000MG, PIPERACILLIN-TAZOBACTAM IV 4.5MG), ASPIRATIONS, ORAL/TOPICAL MEDICATION (LIDOCAINE 5% PATCH, ACETAMINOPHEN-CODEINE 300-30MG, PO LINEZOLID 600 BID AND AUGMENTIN 875 BID X 1 WEEK), DEBRIDEMENT, ANTIBIOTICS, IMPLANT RETENTION DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550536008 LOT NUMBER: 354222 COMPONENT TYPE: GLENOSPHERE UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550035600 LOT NUMBER: 233591 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550300500 LOT NUMBER: 235422 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550011240 LOT NUMBER: 664506 COMPONENT TYPE: B

  Patient problems: Unspecified Infection

  MAUDE report 24389994 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED & DISLOCATED. I&D. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 24165935 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE INFECTION OF RIGHT SHOULDER INCISION, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NOT RELATED, PROCEDURE RELATED: POSSIBLE, DATE OF EVENT: 29 DEC 2025, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: HOSPITALIZATION, DIAGNOSTIC INTERVENTION (VENOUS DUPLEX, ULTRASOUND, MRI, XRAY), INJECTED MEDICATION (VANCOMYCIN IVPB 2000MG, PIPERACILLIN-TAZOBACTAM IV 4.5MG), ORAL/TOPICAL MEDICATION (LIDOCAINE 5% PATCH, ACETAMINOPHEN-CODEINE 300-30MG, PO LINEZOLID 600 BID AND AUGMENTIN 875 BID X 1 WEEK).

  Patient problems: Unspecified Infection

  MAUDE report 24073143 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE INFECTION OF LEFT SHOULDER INCISION, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NOT RELATED, PROCEDURE RELATED: POSSIBLE, DATE OF EVENT: 29 DEC 2025, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT, TREATMENT/IMPACT: HOSPITALIZATION, INJECTED MEDICATION (PT STATES HE IS ON IV ANTIBIOTICS).

  Patient problems: Unspecified Infection

  MAUDE report 24071863 ↗
• 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 23934511 ↗
• InjuryDec 22, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT PATIENT FELL TWICE AND AS A RESULT HAD STEMLESS COMPONENT FAILED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Fall

  MAUDE report 23864115 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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: Unspecified Infection

  MAUDE report 23781040 ↗
• 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: ON (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 23730600 ↗
• 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 23605946 ↗
• InjuryJul 30, 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 DISLOCATION AND PATIENT INSTABILITY, SO SURGEON HAD TO TAKE OUT IMPLANTS AND PUT IN MORE STABLE OPTION. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 22665703 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: UNK DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 21902735 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PATIENT HAD THEIR ORIGINAL SHOULDER DONE, THE SHOULDER BECOME DISLOCATED. ACCORDING TO SURGICAL IMPLANT RECORDS, THE PATIENT WAS IMPLANTED WITH A 40+8 GLENOSPHERE, MEDIUM +8 SHELL, AND A 40 +4 RETENTIVE POLY. WITH THAT CONSTRUCT PRETTY MUCH MAXED OUT, THE SURGEON FELT THE PATIENT'S HUMERAL COMPONENTS WOULD NEED TO BE REVISED AS A WHOLE. THE HUMERAL STEM WAS REMOVED AND THE PATIENT WAS THEN PREPPED FOR A BIOMET HUMERAL COMPONENT. WITH THE BASEPLATE WELL FIXED, THE SURGEON OPTED TO LEAVE IT AND PLACE A 40+8 ECCENTRIC GLENOSPHERE. ONCE THE BIOMET PREP WAS COMPLETE, THE SHOULDER WAS REDUCED AND PUT THROUGH A FULL RANGE OF MOTION AND FOUND TO BE STABLE. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 20751403 ↗
• 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 19513048 ↗
• MalfunctionApr 22, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE GLENOSPHERE WOULD NOT ENGAGE OR SEAT TO THE BASEPLATE. ADDITIONALLY, THE HUMERAL SHELL AND SHORT STEMS TAPER WOULD NOT PROPERLY ENGAGE AND WAS UNEVEN. NO SURGICAL TIME WAS ADDED. DOE: (B)(6) 2024. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 19151526 ↗