INHANCE 5503-00-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295549574), received between Oct 31, 2022 and Sep 3, 2026 — classified as 20 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Subject ID: (b)(6)Study No: DSM202108 Clinical Adverse Event received for Numbness in Fingers following peripheral nerve blockDevice Related: Not Related Procedure Related: PossibleDate of Event: (b)(6) 2026Date of Implant: (b)(6) 2026Date of Revision: No Information ProvidedDevice Location: Left Treatment/Impact: Observation DePuy Synthes Products Used: Catalog Number: 550515290Lot Number: 666230Type: BASEPLATEDescription: INHANCE SHOULDER SYSTEM R/SPEED UNITI PLATFORM BASEPLATE LARGE Ø29mm CEMENTLESSCatalog Number: 550300500Lot Number: 240761Type: SCREWDescription: INHANCE SHOULDER SYSTEM SELF-DRILLING & LOCKING SCREW 4 PACK 20mm & 25mmCatalog Number: 550540004Lot Number: 357663Type: GLENOSPHEREDescription: INHANCE SHOULDER SYSTEM GLENOSPHERE Ø40+4mmCatalog Number: 520000040Lot Number: 6642881Type: HUMERALDescription: INHANCE SHOULDER SYSTEM STEMLESS LARGE DIAMETER 40mm CEMENTLESSCatalog Number: 550000408Lot Number: 659079Type: SHELLDescription: INHANCE SHOULDER SYSTEM REVERSE HUMERAL SHELL LARGE Ø40+8mmCatalog Number: 550040000Lot Number: MI134856Type: LINERDescription: INHANCE SHOULDER SYSTEM REVERSE LINER X-LINKED VITAMIN E PE Ø40+0mm

  Patient problems: Nerve Damage; Numbness

  MAUDE report 50589483 ↗
• 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 25457150 ↗
• MalfunctionApr 20, 2026Fracture

  IT WAS REPORTED THAT THE SCREW HEAD DETACHED DURING SURGERY, AND THE REMAINING SCREW STAYED IN THE PATIENT'S GLENOID. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. AFFECTED SIDE-UNKNOWN.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 24930003 ↗
• InjuryApr 13, 2026Migration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO SHIFT IN POSITION OF GLENOID COMPONENTS. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 24857829 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(4). 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 FLORIDA 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 24389928 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DSM202108. 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 24073126 ↗
• 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 24071832 ↗
• InjuryDec 26, 2025Osseointegration Problem; Osseointegration Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). 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); ENHANCE REVERSE SHOULDER ARTHROPLASTY WAS REVISED AND CONVERTED TO AN ENHANCE HEMIARTHROPLASTY, FOR TREATMENT OF ASEPTIC LOOSENING OF THE ENHANCE BASEPLATE AND SCREWS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23896054 ↗
• InjuryDec 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 FOR INFECTION. THE INFECTED PRODUCTS WERE EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23814256 ↗
• 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 23781063 ↗
• 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)(6). 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 NU

  Patient problems: Pain

  MAUDE report 23768563 ↗
• 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 TYPE:

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23286018 ↗
• 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 22978550 ↗
• 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 22649776 ↗
• 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 22097962 ↗
• InjuryMay 15, 2025Osseointegration Problem; Osseointegration 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: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 22029243 ↗
• InjuryJun 20, 2024Adverse 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 PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 19574833 ↗
• 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. 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 18940898 ↗
• InjuryJul 14, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO GLENOID COMPONENT LOOSENING. SURGEON STATES IT WAS DUE TO POOR BONE QUALITY. ENTIRE CONSTRUCT WAS REMOVED AND DELTA XTEND W/ CTA HEAD WAS PUT INTO PLACE DUE TO POOR BONE QUALITY. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Inadequate Osseointegration; Unspecified Tissue Injury

  MAUDE report 17324521 ↗
• InjuryMay 15, 2023Osseointegration Problem; Osseointegration Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING. DOI: (B)(6) 2023. DOR: (B)(6) 2023 . RIGHT SHOULDER. TREATMENT: METAGLENE AND GLENOSPHERE WERE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16933536 ↗
• MalfunctionMar 22, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN PLACING LOCKING SCREWS INTO THE BASEPLATE, IT WAS NOTICED BY THE SURGEON THAT THE SCREW PASSED THROUGH THE BASEPLATE SCREW HOLE ENTIRELY WITHOUT ENGAGING AND LOCKING INTO THE BASEPLATE. HE WAS ABLE TO BACK THE SCREW OUT AND RE-ENGAGE IT TO THE PLATE. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 16590775 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS BEING REVISED DUE TO PAIN AND DISCOMFORT IN THEIR SHOULDER. DR INFORMED THAT THE PATIENT FELT A POP FOLLOWED BY PAIN AFTER LIFTING SOMETHING ABOVE THEIR HEAD. DR.¿S PA INFORMED THAT THERE MAY HAVE BEEN A FRACTURE OF THE PATIENTS GLENOID. DR REMOVED THE GLENOID AND HUMERAL COMPONENTS AND OPTED TO REVISE THE PATIENT WITH ZIMMER-BIOMET IMPLANTS. ONCE THE IMPLANTS WERE REMOVED, DR TOLD THE REP THAT HE WOULD BE GOING WITH ZIMMER-BIOMET, AND THAT HE NO LONGER NEEDED REP'S ASSISTANCE IN THE ROOM. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Bone Fracture(s); Discomfort; Pain

  MAUDE report 16551762 ↗
• MalfunctionOct 31, 2022Difficult to Insert; Naturally Worn; Difficult to Insert; Naturally Worn

  IT WAS REPORTED THAT THE SURGEON HAD IMPLANTED A SMALL BASEPLATE WITH A 25MM CENTRAL SCREW. HE WAS LOOKING TO GAIN SOME ADDITIONAL COMPRESSION, SO HE ASKED FOR THE PERIPHERAL DRILL SO HE COULD DRILL FOR SOME NON LOCKING SCREWS. THE DRILL GUIDE WAS USED, AND THEN THE SURGEON MEASURED FOR A 20MM SCREW. WHEN IMPLANTING THE SCREW, THE SURGEON SAID THAT THE SCREW WENT DIRECTLY THROUGH THE BASEPLATE. HE ASKED FOR A DIFFERENT 20MM NON-LOCKING SCREW, AND THAT SCREW ALSO WENT THROUGH THE BASEPLATE. AT THIS POINT, THE SURGEON OPTED TO IMPLANT LOCKING SCREWS, SO HE ASKED FOR THE SELF DRILLING & LOCKING SCREW PACK. WHEN IMPLANTING ONE OF THE LOCKING SCREWS, THAT ALSO WENT THROUGH THE BASEPLATE. WHEN THE SURGEON ATTEMPTED TO BACK THE LOCKING SCREW OUT, HE INFORMED ME THAT IT MUST HAVE CROSS THREADED ITSELF INTO THE PLATE, WHERE IT EVENTUALLY LOCKED INTO THE PLATE. HE ASKED THAT I WRITE THESE IMPLANTS UP AND HAVE THE SCREWS RETURNED TO BE ANALYZED. HE ALSO MENTIONED TO ME HIS DISAPPOINTMENT IN THE ¿PICK & STICK¿ ASPECT OF THE PERIPHERAL SCREWS. HE SAID THAT THEY JUST DON¿T SEEM TO LOCK ONTO THE T20 SCREWDRIVER THE WAY THAT THEY SHOULD. THERE WAS NO REPORTED LOOSENING. THERE WAS A REPORTED SURGIC

  Patient problems: Insufficient Information

  MAUDE report 15698608 ↗