INHANCE 5500-11-240Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295553212), received between Jun 6, 2025 and Sep 22, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 16 most recent of 16 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 there was an infection. No other information was provided. DOI: Unknown.DOR: (b)(6), 2026.Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50853723 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that all In hance reverse implants were explanted due to infection.DOI: (b)(6) 2026,DOR: (b)(6) 2026,Affected Side: Unknown Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50751198 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR PAIN. DOI-UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE-UNKNOWN.

  Patient problems: Pain

  MAUDE report 25456864 ↗
• InjuryMay 4, 2026Device Dislodged or Dislocated; Osseointegration Problem; 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: Inadequate Osseointegration

  MAUDE report 25073220 ↗
• 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: 05 FEB 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 NUMBER: 550310035 LOT

  Patient problems: Joint Laxity; Pain

  MAUDE report 24615904 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DSM202108. CLINICAL ADVERSE EVENT RECEIVED FOR JOINT EFFUSION (POSSIBLE INFECTION OF RIGHT SHOULDER INCISION. PT CALLED OFFICE ON (B)(6) 2025 STATES HE WAS ADMITTED TO HOSPITAL IN FLORIDA ON (B)(6) 2025 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 N

  Patient problems: Unspecified Infection

  MAUDE report 24389951 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). 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: ON (B)(6) 2025, DATE OF REVISION: ON (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: INHANC

  Patient problems: Unspecified Infection

  MAUDE report 24233404 ↗
• 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 24073139 ↗
• 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 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 24071858 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE SUBLUXATION EVENT. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: PROBABLE. DATE OF EVENT: 20 DEC 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: OTHER NON-SURGICAL TREATMENTS: YES. (SPECIFY: HOLD FORMAL PT AND RESUME USING THE SHOULDER IMMOBILIZER FOR THE NEXT 3 WEEKS. HE CAN DO PENDULUM EXERCISES BUT WILL HOLD ON TO THE REMAINDER OF HIS HOME EXERCISE PROGRAM. IN THREE WEEKS, HE CAN WEAN FROM THE IMMOBILIZER AGAIN AND RESUME OUTPATIENT PT.)

  Patient problems: Joint Laxity

  MAUDE report 24042673 ↗
• 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 24039065 ↗
• InjuryDec 26, 2025Osseointegration Problem; Osseointegration Problem

  SUBJECT ID: (B)(6) STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR SHOULDER REVISION DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: NO INFORMATION PROVIDED. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: WERE DEPUY SYNTHES COMPONENTS REMOVED: YES. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: (B)(6) 2025, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: WERE DEPUY SYNTHES COMPONENTS REMOVED: YES (CUP, METAGLENE, HEAD/GLENOSPHERE); INHANCE REVERSE SHOULDER ARTHROPLASTY WAS REVISED AND CONVERTED TO AN INHANCE HEMIARTHROPLASTY, FOR TREATMENT OF ASEPTIC LOOSENING OF THE INHANCE BASEPLATE AND SCREWS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23896031 ↗
• InjuryDec 11, 2025Osseointegration Problem; Osseointegration 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: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 23781146 ↗
• 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: ON (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

  Patient problems: Pain

  MAUDE report 23768417 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL ADVERSE EVENTS WERE RECEIVED FOR CONJOINED TENDINITIS: DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: NOT RELATED, PROCEDURE RELATED: POSSIBLE, DATE OF EVENT: 05 SEP 2025, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: NO INFORMATION PROVIDED. SUBJECT ID: (B)(6), STUDY NO: (B)(6). TREATMENT/IMPACT: REHABILITATION, INJECTED MEDICATION (SPECIFY: 2 ML OF 1% LIDOCAINE 2 ML OF 0.25% MARCAINE AND 2 ML OF BETAMETHASONE) AND ORAL/TOPICAL MEDICATION. DEPUY SYNTHES PRODUCT USED: CATALOG NUMBER: 520000036, LOT NUMBER: 662705, COMPONENT TYPE: HUMERAL, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550011240, LOT NUMBER: 663951, COMPONENT TYPE: BASEPLATE, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550300500, LOT NUMBER: 229406, COMPONENT TYPE: SCREW, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550040600, LOT NUMBER: 206414, COMPONENT TYPE: SCREW, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550532008, LOT NUMBER: 347232, COMPONENT TYPE: GLENOSPHERE, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550000360, LOT NUMBER: 664116, COMPONENT TYPE: SHELL, UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550032000, LOT NUMBER: MI1777, COMPONENT TYP

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23286831 ↗
• InjuryJun 6, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVERSE TOTAL SHOULDER DONE IN (B)(6). 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 22160527 ↗