INHANCE 5503-10-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295546573), received between Sep 19, 2023 and Sep 22, 2026 — classified as 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (3 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 21 most recent of 21 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 infection. No other information was provided.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50853872 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that infection. DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50853819 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revision due to infection/fracture from fall.DOI: (b)(6) 2025,DOR: (b)(6) 2026,Affected Side: Right.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 50771656 ↗
• MalfunctionSep 11, 2026Fracture

  It was reported that the screw head snapped off while implanting in the patient. The shaft of the screw was still in the patient.

  Patient problems: Foreign Body In Patient

  MAUDE report 50735198 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  (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 DEVICE ID: (B)(4) CATALOG NUMBER: 550011240 LOT NUMBER: 665007 COMPONENT T

  Patient problems: Loss of Range of Motion; Nerve Damage

  MAUDE report 25325138 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED THE PATIENT EXPERIENCED PERSISTENT INSTABILITY IN THE LEFT SHOULDER FOLLOWING A REVERSE TOTAL SHOULDER ARTHROPLASTY, DESPITE INITIAL POSTOPERATIVE IMPROVEMENT. IMAGING CONFIRMED STABLE ALIGNMENT OF THE IMPLANT, AND THE INSTABILITY DID NOT RESULT IN A TRUE GLENOHUMERAL DISLOCATION. PERSISTENT SYMPTOMS LED TO A DIAGNOSTIC CT SCAN TO ASSESS PROSTHESIS STABILITY AND POSITION. DEVICE RELATED: POSSIBLE (HUMERAL STEMLESS IMPLANT: YES). PROCEDURE RELATED: POSSIBLE. DATE OF EVENT: (B)(6) 2026. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: DIAGNOSTIC INTERVENTION (CT). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 520000036; LOT NUMBER: 662988; COMPONENT TYPE: HUMERAL; DESCRIPTION: INHANCE SHOULDER SYSTEM STEMLESS MEDIUM DIAMETER 36MM CEMENTLESS. CATALOG NUMBER: 550011240; LOT NUMBER: 664496; COMPONENT TYPE: : BASEPLATE; DESCRIPTION: INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS. CATALOG NUMBER: 550035600; LOT NUMBER: 206439; COMPONENT TYPE: SCREW; DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM. CATALOG NUMB

  Patient problems: Joint Laxity; Pain

  MAUDE report 24616300 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 24574721 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVERSED TOTAL SHOULDER REVISION OCCURRED DUE TO GLENOSPHERE AND LINER IMPINGEMENT. PATIENT WAS CONVERTED TO HEMI ARTHOPLASTY. DURING THE PROCEDURE THE HEAD TRIAL WAS DAMAGED WHERE THE ADAPTOR FOR HEAD AND TRIAL MEET. THE ATTACHMENT TABS BROKE OFF. THERE WAS NO HARM TO PATIENT AND NO SURGICAL DELAY. DOE: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 24187699 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SHOULDER WAS INFECTED, SURGEON PULLED COMPONENTS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 24039478 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FROM INDEX SURGERY DONE A FEW YEARS AGO: REVISED OUT 20MM LOCKING SCREW (TOO LONG CAUSING PAIN WAS DIAGNOSIS). REMOVED 32+4 GLENOSPHERE, 32 +0 POLY. FROM REVISION: UPON IMPACTING A NEW 32+4 GLENOSPHERE THE IMPACTOR TIP SNAPPED OF IN IT AS MORSETAPER ENGAGED BLOCKING USE OF CENTRAL FIXATION SCREW. HAD TO REMOVE AND DISCARD THIS IMPLANT AND REPLACE W ANOTHER WHICH WAS A 36 BC ONLY ONE 32 WAS AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 23881685 ↗
• InjuryJul 25, 2025Fracture; Fracture

  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 22616583 ↗
• InjuryJul 24, 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: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22594422 ↗
• InjuryJul 16, 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 INFECTION. ALL COMPONENTS WERE TAKEN OUT. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22522970 ↗
• InjuryJun 6, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVERSE TOTAL SHOULDER DONE IN APRIL. THE BASE PLATE PULLED OUT OF THE GLENOID SHORTLY THEREAFTER DUE TO INCREDIBLY POOR BONE STOCK. THERE WAS NON-CEMENTED LOOSENING OF THE BASEPLATE. SURGEON REMOVED THE BASEPLATE AND CONVERTED TO A HEMI. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22160640 ↗
• InjuryNov 11, 2024Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO SURGICAL DELAY. B. WHAT WAS THE REASON FOR REPLACING THE GLENOSPHERE AND THE CUP? HAD TO REMOVE TO GET SCREWS OUT AND PUT NEW IMPLANTS IN.

  Patient problems: Pain

  MAUDE report 20653823 ↗
• MalfunctionOct 14, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE LOCKING SCREW WENT STRAIGHT THROUGH THE BASEPLATE HOLE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439379 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIS RIGHT SHOULDER REPLACED BY THE PRIMARY SURGEON ON (B)(6) 2022 WHERE HE RECEIVED A DELTA EXTEND REVERSE SHOULDER CONSTRUCT. HE CAME TO THE REVISING SURGEON EARLIER THIS YEAR WITH SHOULDER PAIN WHERE THE SURGEON REVISED THE CONSTRUCT BECAUSE OF A LOOSE BASEPLATE. UNFORTUNATELY, THE PATIENT SHOULDER BECAME INFECTED FOLLOWING THE REVISION. THE REVISING SURGEON THEN REVISED THE SHOULDER AND EXPLANTED ALL OF THE COMPONENTS AND IMPLANTED A ANTIBIOTIC SPACER. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 19710804 ↗
• InjuryMar 23, 2024Migration; Migration

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 18966118 ↗
• InjuryMar 23, 2024Migration; Migration

  IT WAS REPORTED THAT THE BASEPLATE AND GLENOSPHERE MOVED FROM ORIGINAL SURGERY FROM A GLENOID FRACTURE. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 18966100 ↗
• InjuryMar 23, 2024Migration; Migration

  IT WAS REPORTED THAT THE BASEPLATE AND GLENOSPHERE MOVED FROM ORIGINAL SURGERY FROM A GLENOID FRACTURE. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 18966093 ↗
• InjurySep 19, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD REVERSE SHOULDER DONE ON (B)(6) 2023. SURGEON INFORMED THAT THE PATIENT HAD NOT BEEN COMPLIANT IN FOLLOWING POST SURGERY RESTRICTIONS. PATIENT CONTINUED DOING ACTIVITIES WHICH SHOULD NOT HAVE DONE AFTER SURGERY, WHICH IS BELIEVED TO HAVE LEAD TO THE GLENOSPHERE FRACTURING AND BECOMING LOOSE. SURGEON FELT THE BONE QUALITY THAT WAS LEFT IN THE GLENOID WAS NOT SUITABLE FOR A REVISION AND OPTED TO CONVERT THE PATIENT TO A HEMI SHOULDER. SURGEON REMOVED MOST OF THE REVERSE IMPLANTS, LEAVING THE HUMERAL COMPONENT BEHIND. A TRIAL HEAD REDUCTION WAS PERFORMED AND FOUND TO BE ADEQUATE. THE REAL HEAD WAS OPENED AND IMPLANTED. DOI: (B)(6) 2023, DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 17775210 ↗