INHANCE 5200-01-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295538196), received between Jul 11, 2023 and Apr 21, 2026 — classified as 14 injuries, 1 malfunction.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD LOOSE STEM FOLLOWING PERIPROSTHETIC FRACTURE. HUMERAL STEM WAS LOOSE AT BONE TO IMPLANT(NON-CEMENTED) INTERFACE.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 24936150 ↗
• 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 24568382 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NO INFORMATION PROVIDED, PROCEDURE RELATED: NO INFORMATION PROVIDED, DATE OF EVENT: 8 JAN 2026, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: (B)(6) 2026, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: COMPONENTS REMOVED (CUP). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550011240, LOT NUMBER: 664514, COMPONENT TYPE: BASEPLATE, DESCRIPTION: MODULAR UNITI PLATFORM BASEPLATE S 24. CATALOG NUMBER: 550030600, LOT NUMBER: 227541, COMPONENT TYPE: SCREW, DESCRIPTION: INHANCE CENTRAL SCREW 6.0X30. CATALOG NUMBER: 550300500, LOT NUMBER: 235418, COMPONENT TYPE: SCREW, DESCRIPTION: INHANCE 4PK LOCKING SCRW 2025 SLFDRILL. CATALOG NUMBER: 550536004, LOT NUMBER: 350285, COMPONENT TYPE: GLENOID, DESCRIPTION: INHANCE GLENOSPHERE 36+4. CATALOG NUMBER: 520001040. LOT NUMBER: 664294. COMPONENT TYPE: STEM. DESCRIPTION: INHANCE SHORT STEM L 40. CATALOG NUMBER: 550000400, LOT NUMBER: 664524, COMPONENT TYPE: SHELL, DESCRIPTION: INHANCE REVERSE HUMERAL SHELL L 40+0. CATALOG NUMBER: 550036104, LOT NUMBER: MI125080, COMPONENT TYPE: LINER, DESCRIPTION: INHANCE REVE

  Patient problems: Unspecified Infection

  MAUDE report 24233179 ↗
• MalfunctionOct 22, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SHELL WOULD NOT PROPERLY SEAT ON THE STEM. NORMAL TECHNIQUE WAS USED TO SEAT THE SHELL. SURGEON TRIED TWICE. BOTH TIMES, THE SHELL SEEMED CROOKED AND THE SURGEON REQUESTED NEW IMPLANTS. NEW PRODUCTS NEEDED TO BE SENT TO REPLACE THESE TWO IMPLANTS. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23356400 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GROSSLY INFECTED HAD TO REMOVE IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22977519 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POSTOPERATIVELY PATIENT HAD A FRACTURE IN HUMERUS AND HAD TO REVISED TO A LONGER STEM. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 22804897 ↗
• 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 22645084 ↗
• 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 22522959 ↗
• InjuryJun 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO HUMERAL STEM FRACTURE POST TOTAL SHOULDER. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 22228612 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN COMPLAINING OF PAIN A 1-2 WEEKS AGO. A CT SCAN WAS DONE AND IT WAS DISCOVERED THAT THE INHANCE REVERSE LINER COULD BE SEEN FLOATING IN THE SHOULDER AND WAS NOT ATTACHED TO THE HUMERAL SHELL/STEM CONSTRUCT. IT ALSO SHOWED WHAT APPEARED TO BE METALLOSIS INDICATING THAT THE GLENOSPHERE HAD BEEN RUBBING ON THE FACE OF THE HUMERAL SHELL. REVISION SURGERY WAS DONE ON (B)(6) 2025. THERE WAS A SIGNIFICANT AMOUNT OF METAL DEBRIS AND METALLOSIS ON THE BONE AND THE SURROUNDING TISSUE. IT IS UNKNOWN HOW LONG THE POLY HAD BEEN OUT OF PLACE BUT BY THE DAMAGE DONE TO THE IMPLANTS AS WELL AS THE AMOUNT OF METALLOSIS, IT SEEMED TO HAVE HAPPENED QUITE A WHILE BACK. THE GLENOSPHERE HAD WORN A DIVOT IN THE FACE OF THE SHELL. SURGEON WAS ABLE TO REMOVE THE GLENOSPHERE, THE HUMERAL SHELL, THE STEM, AND RETRIEVED THE POLY. THE BASEPLATE AND SCREWS WERE WELL FIXED AND STAYED IMPLANTED. THE SURGEON CLEANED/REMOVED THE METAL DEBRIS AND METALLOSIS OUT OF THE BONE AND TISSUE. THE SURGEON WAS ABLE TO REVISE TO A LARGER AND LONGER STEM AND ACHIEVE GOOD FIXATION, HE PUT ON A NEW GLENOSPHERE OF THE SAME SIZE AND TRIALED A FEW HUMERAL SHELL AND POLY COMBINATIONS TO DETERMIN

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 21551962 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY REPORTED AND THE FRACTURE WAS DISCOVERED ON POST OP X-RAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 19808100 ↗
• InjuryJun 4, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO PAIN FROM LOOSE HUMERAL COMPONENT. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE : RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 19459572 ↗
• InjuryMar 15, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO DISLOCATION. STEM WAS LOOSE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18913381 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STIFFNESS AND PAIN. THERE WAS NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 17850276 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WAS SUSPICION OF INFECTION. IT IS UNKNOWN IF INFECTION WAS PRESENT. IMPLANTS WERE REMOVED. IT WAS THEN WASHED OUT AND NEW IMPLANTS WERE INSERTED. DOI: (B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17297864 ↗