INHANCE 5200-00-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295538257), received between Dec 9, 2022 and May 28, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: (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: 4 FEB 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:

  Patient problems: Loss of Range of Motion; Nerve Damage

  MAUDE report 25325095 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND HAD A PERI PROSTHETIC FRACTURE. IMPLANTS REVISED DUE TO THE FRACTURE. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 24894419 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ANATOMIC SHOULDER ARTHROPLASTY DONE ON (B)(6) 2025. PATIENT STATED THEY WERE DOING WELL FOR 4-5 MONTHS UNTIL THEY SUDDENLY COULDN¿T LIFT THEIR ARM DUE TO A SUBSCAP TEAR. TODAY, THE PATIENT WAS CONVERTED FROM AN ANATOMIC SHOULDER TO A REVERSE SHOULDER. THE ANATOMIC HUMERAL HEAD WAS REMOVED ALONG WITH THE OFFSET TAPER ADAPTER, THE HYBRID GLENOID WAS REMOVED AND REPLACED WITH A REVERSE BASEPLATE. STEMLESS COMPONENT WAS REMOVED AND REPLACED WITH A STANDARD STEM. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24790324 ↗
• InjuryApr 1, 2026Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR LOOSE STEMLESS HUMERAL STUDY IMPLANT DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 09 MAR 2026. DATE OF IMPLANT: (B)(6) 2026. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. DEVICE RELATED: PROBABLE. PROCEDURE RELATED: PROBABLE. TREATMENT/IMPACT: RESULTED IN MEDICAL OR SURGICAL INTERVENTION (STUDY SHOULDER), HUMERAL STEMLESS IMPLANT: YES DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 520000036. LOT NUMBER: 662705. COMPONENT TYPE: HUMERAL. DESCRIPTION: INHANCE SHOULDER SYSTEM STEMLESS MEDIUM DIAMETER 36MM CEMENTLESS. CATALOG NUMBER: 550515290. LOT NUMBER: 664835. COMPONENT TYPE: BASEPLATE. DESCRIPTION: INHANCE SHOULDER SYSTEM R/SPEED UNITI PLATFORM BASEPLATE LARGE Ø29MM CEMENTLESS. CATALOG NUMBER: 550300500. LOT NUMBER: 235420. COMPONENT TYPE: SCREW. DESCRIPTION: INHANCE SHOULDER SYSTEM SELF-DRILLING & LOCKING SCREW 4 PACK 20MM & 25MM. CATALOG NUMBER: 550540004. LOT NUMBER: 356726. COMPONENT TYPE: GLENOSPHERE. DESCRIPTION: INHANCE SHOULDER SYSTEM GLENOSPHERE Ø40+4MM. CATALOG NUMBER: 550000360. LOT NUMBER: 664537. COMPONENT TYPE: SHELL. DESC

  Patient problems: Insufficient Information

  MAUDE report 24754795 ↗
• 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 24615744 ↗
• 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) 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 NUMB

  Patient problems: Unspecified Infection

  MAUDE report 24389978 ↗
• 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 24073149 ↗
• 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 24071860 ↗
• InjuryDec 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: CAN YOU PLEASE CONFIRM IF THIS IS LEFT OR RIDE SIDE? IT WAS THE PATIENT¿S RIGHT SHOULDER, AND THE HUMERAL HEAD AND TAPER ADAPTER (AS A CONSTRUCT) WERE DISASSOCIATED FROM THE STEMLESS IMPLANT. THE STEMLESS IMPLANT WAS WELL FIXED, SO THE SURGEON LEFT IT IN AND REPLACED THE HEAD AND ADAPTER WITH A NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 23887398 ↗
• InjuryDec 22, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT PATIENT FELL TWICE AND AS A RESULT HAD STEMLESS COMPONENT FAILED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Fall

  MAUDE report 23864022 ↗
• InjuryDec 11, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE IMPLANT LOOSENED. THE LOOSE COMPONENT WAS THE HUMERAL STEM. IT WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23782979 ↗
• InjuryNov 25, 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 A TORE ROTATOR CUFF AND SUBSCAP DURING REHABILITATION. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23646248 ↗
• InjuryAug 15, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS ENROLLED IN THE STEMLESS REVERSE IDE STUDY. SHE EXPERIENCED A FAILURE OF THE HUMERAL COMPONENT. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 22815655 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ROTATOR CUFF TEAR. DOI: ON (B)(6) 2023. DOR: ON (B)(6) 2024. AFFECTED SIDE : RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19829437 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SUBSCAPULARIS FAILURE AND THE IMPLANTS WERE CONVERTED TO A REVERSE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18300338 ↗
• InjuryMar 27, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE STEMLESS COMPONENT MALPOSITIONED IN PREVIOUS SURGERY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 16618540 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STABILITY ISSUES THAT WERE NOT IMPLANT RELATED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022 RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 15953437 ↗