INHANCE 5505-36-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295546696), received between Oct 7, 2022 and Sep 16, 2026 — classified as 25 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to impingement/infection. The surgeon performed washout and reimplantation of prosthesis. DOI: On (b)(6) 2024.DOR: On (b)(6) 2026.Affected Side: Right Shoulder.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 50791379 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 25395188 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR EXPLANT AND WASHOUT OF JOINT DUE TO INFECTION. GLENOSPHERE, HUMERAL SHELL, AND POLY WERE REVISED. NO MORE INFORMATION AT THIS TIME. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 25317150 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 25116087 ↗
• InjuryMay 4, 2026Device Dislodged or Dislocated; No Apparent Adverse Event

  IT WAS REPORTED THAT UPON REVIEW OF X RAY, IT APPEARS THE GLENOSPHERE HAS DISASSOCIATED FROM GLENOID BASEPLATE. IT WAS STATED THAT THERE WAS LOOSENING AND THE LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT. DOI: (B)(6) 2026. DOR: UNKNOWN. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 25073281 ↗
• InjuryMar 25, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION POLY/GLENO WAS SWAP. DOI: UNKNOWN DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 24691459 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT I/D POLY AND GLENO SWAP. DOI-UNKNOWN, DOR - (B)(6) 2026, AFFECTED SIDE-RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 24491494 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). 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 (B)(6) 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:

  Patient problems: Unspecified Infection

  MAUDE report 24389801 ↗
• 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 24187993 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). 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 24073117 ↗
• 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 24071816 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS NOT STABLE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23991181 ↗
• InjuryJan 7, 2026Device Dislodged or Dislocated; No Apparent Adverse Event; Noise, Audible

  SUBJECT ID: (B)(6) STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE COMPONENT DISLOCATION, PT CALLED OFFICE STATING HE WAS CARRYING AN ITEM DOWN THE HALL AND GOT CAUGHT ON THE CORNER AND HEARD A POP AND NOTICES A CLEAR BULGE IN HIS ARM. PT IS HEADED TO THE ED AND SCHEDULED MONDAY WITH DR. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: PROBABLE. PROCEDURE RELATED: CAUSAL RELATIONSHIP. DATE OF EVENT: 12 DEC 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: DIAGNOSTIC INTERVENTION: YES (SPECIFY: XRAYS). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550011240. LOT NUMBER: 664507. COMPONENT TYPE: BASEPLATE. DESCRIPTION: INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS. CATALOG NUMBER: 550300500. LOT NUMBER: 235422. COMPONENT TYPE: SCREW. DESCRIPTION: INHANCE SHOULDER SYSTEM SELF-DRILLING & LOCKING SCREW 4 PACK 20MM & 25MM. CATALOG NUMBER: 550035600. LOT NUMBER: 232001. COMPONENT TYPE: SCREW. DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM. CATALOG NUMBER: 550536008. LOT NUMBER: 354226. COMPONENT TYPE: GLENOSPHERE. DESCRIPTION: INHANCE SHOULDER SYSTEM GLEN

  Patient problems: Joint Dislocation

  MAUDE report 23988584 ↗
• InjuryJan 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AFTER LIFTING OBJECT FROM THE GROUND. NO LOOSENING OF ANY COMPONENTS. INCREASED POLY AND LATERALIZATION TO RESOLVE.

  Patient problems: Joint Dislocation

  MAUDE report 23972185 ↗
• MalfunctionDec 9, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT GLENOSPHERE SCREW WOULD NOT LOCK IN TO BASEPLATE. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760461 ↗
• MalfunctionDec 8, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT GLENOSPHERE SCREW WOULD NOT LOCK IN TO BASEPLATE. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746623 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND THE IMPLANTS NEEDED TO BE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22649769 ↗
• InjuryJun 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS PATIENT HAD THEIR ORIGINAL SURGERY DONE ON (B)(6) 2023. PATIENT WAS BROUGHT BACK DUE TO INSTABILITY AFTER LOSING OVER 100LBS IN 9 MONTHS AND FINDING THAT THE GLENOSPHERE HAD DISASSOCIATED FROM THE BASEPLATE. THE GLENOSPHERE WAS REMOVED AS WELL AS THE HUMERAL SHELL, AND POLY TO GAIN ACCESS TO THE GLENOID. A LARGER GLENOSPHERE WAS THEN IMPLANTED, AND A NEW SHELL AND POLY AS WELL. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22207060 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND WASH OUT. SWAPPED OUT IMPLANTS THAT WERE EASILY REMOVED (GLENOSPHERE, POLY, SHELL, SCREWS). DID NOT TAKE OUT STEM OR R SPEED AS WAS VERY INGROWN. NO IMPLANT FAILURE. UNSURE OF WHERE INFECTION CAME FROM. NO BROKEN IMPLANTS. NO PIECES LEFT BEHIND. NO CASE DELAY. NO OTHER INFORMATION KNOWN. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22097792 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE BASEPLATE AT THE BONE TO IMPLANT INTERFACE. PATIENT DEVELOPED INFLECTION. ALL IMPLANTS EXPLANTED. CEMENT SPACER IMPLANTED. STEM WAS WELL-FIXED. DOI: UNKNOWN DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22029247 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR IMPINGEMENT. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 21592502 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RUPTURED THE SOFT TISSUE REPAIR THAT LED TO COMPONENT SUBLUXATION. THERE WAS NO LOOSENING. DEPUY CEMENT WAS USED. DOI: UNKNOWN AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 21256945 ↗
• InjuryOct 9, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE GLENOSPHERE DID NOT SEAT ON THE BASEPLATE PROPERLY. THE SURGEON SAID THERE WAS AN ISSUE WITH THE TAPER. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20408218 ↗
• InjuryApr 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. PATIENT HAD ORIGINAL SURGERY DONE AT HOSPITAL ON (B)(6) 2024. UNFORTUNATELY THEY DISLOCATED AND NEEDED TO BE REVISED. SURGEON REMOVED THE POLY, SHELL, AND GLENOSPHERE. A BIGGER GLENOSPHERE WAS IMPLANTED TO INCREASE STABILITY. THERE WAS NO ADVERSE EVENTS OR DELAYS TOOK PLACE. DOI: (B)(6) 2024. DOR: UNKNOWN. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 19212987 ↗
• 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 19151525 ↗