INHANCE 5200-00-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295538240), received between Feb 3, 2023 and Aug 3, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 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)(6).Clinical Adverse Event received for closed nondisplaced fracture of acromial process of right scapulaDevice Related: Not relatedProcedure Related: ProbableDate of Event: 25 Jul 2025Date of Implant: (b)(6) 2025Date of Revision: No information providedDevice 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: YesDiagnostic 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: YESSurgical intervention for the study shoulder: YESStaged revision: YESDePuy Synthes Products Used:Catalog Number: 520000040Lot Number: 662039Component Type: HUMERALDescription: INHANCE SHOULDER SYSTEM STEMLESS LARGE DIAMETER 40mm CEMENTLESS.Catalog Number: 550000400Lot Number: 664523Component Type: SHELLDescription: INHANCE SHOULDER SYSTEM REVE

  Patient problems: Bone Fracture(s)

  MAUDE report 50119667 ↗
• 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 NUMBER: 664523 COMPONENT TYPE

  Patient problems: Pain

  MAUDE report 23767807 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED AN SHOULDER. REVISION WAS PERFORMED. IT WAS REPORTED THAT IT WAS NOT RELATED TO ANY DEPUY PRODUCT. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 23378460 ↗
• InjuryJul 10, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT THE DOCTOR WAS DISPLEASED WITH IMMEDIATE POST-OPERATIVE RADIOGRAPHS AND REACQUIRED NEW RADIOGRAPHS. SUBJECT HAD UNDERGONE A REVERSE TOTAL SHOULDER ARTHROPLASTY AND RECEIVED THE INHANCE STEMLESS (TREATMENT) HUMERAL IMPLANT. THE POSTOPERATIVE RADIOGRAPHS INDICATED THAT THE IMPLANT HAS SHIFTED WITHIN THE BONE AND THE DOCTOR HAS DISCUSSED THIS WITH THE SUBJECT. DOCTOR HAS PERFORMED A REVISION SURGERY TO EXPLANT THE INHANCE STEMLESS HUMERAL IMPLANT. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 22468452 ↗
• InjuryJun 27, 2025Loss of or Failure to Bond; Osseointegration Problem; Loss of or Failure to Bond; Osseointegration Problem

  STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR "FAILED LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY WITH HUMERAL COMPONENT LOOSENING". DEVICE AND PROCEDURE (RELATEDNESS) RELATIONSHIP TO STUDY DEVICE: CAUSAL RELATIONSHIP NO RELATIONSHIP TO PRIMARY STUDY PROCEDURE: PROBABLE. DEVICE LOCATION: LEFT TREATMENT/IMPACT: SURGICAL INTERVENTION FOR THE STUDY SHOULDER: YES SINGLE-STAGE REVISION: YES.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 22344390 ↗
• InjuryJun 26, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE STEMLESS REVERSE SPUN OUT, THE SUPERIOR MEDIAL WALL OF THE HUMERUS WAS BLOWN OUT. THERE WAS LOOSENING OF STEMLESS COMPONENT. SURGEON STATE IT LOOKED TRAUMATIC BUT PATIENT REPORTED NO INCIDENT. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 22337110 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A FRACTURE AROUND HIS IMPLANT. THE HUMERAL IMPLANT, SHELL, AND LINER WERE REMOVED AND A LONG STEM, SHELL AND LINER REPLACED IT. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN; DOR- (B)(6) 2024; AFFECTED SIDE- LEFT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 20722524 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TORE SUBSCAP AND ROTATOR CUFF. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20368843 ↗
• MalfunctionJun 4, 2024Use of Device Problem; Use of Device Problem

  A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO. B. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457551 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT INITIAL SURGERY WAS DONE (B)(6) 2023 BY THE SURGEON AT HOSPITAL. PATIENT WAS THEN REVISED DUE TO INSTABILITY ON (B)(6) 2023. THE SURGEON WAS UNABLE TO FIND THE MDR NUMBER FOR THAT FIRST REVISION. UNFORTUNATELY THE PATIENT CAME BACK AGAIN, BUT THIS TIME FOR INFECTION. ALL IMPLANTS WERE REMOVED AND THE SHOULDER WAS THOROUGHLY WASHED. THERE WAS NO SURGICAL DELAYS OR ADVERSE EVENTS TOOK PLACE. THE SHOULDER WAS CLOSED AFTER A THOROUGH WASHOUT. DOI: (B)(6) 2023. DOR: UNKNOWN. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 18940924 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SHOULDER DISLOCATION APPROX 8 WEEKS POST-OP. SURGEON REVISED THE JOINT DUE TO INSTABILITY. THERE WAS NO DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 18902470 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SHOULDER WAS NOT STABLE, NEEDED TO GO TO A REVERSE. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 16297216 ↗