INHANCE 5503-10-035Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295546603), received between Oct 3, 2024 and Jun 17, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Fracture

  IT WAS REPORTED THAT BONE WAS DENSE AND THE SCREW WAS OVER-TORQUED DURING INSERTION, CAUSING THE HEAD TO BREAK OFF. THE BROKEN SCREW WAS REMOVED AND DISPOSED OF. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534263 ↗
• InjuryJun 9, 2026Fracture

  IT WAS REPORTED THAT THE SHOULDER WAS REVISED BECAUSE OF BROKEN PERIPHERAL AND CENTER SCREW. IMPLANTS WERE REMOVED AND REPLACED. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25446589 ↗
• 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: (B)(6) 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 NUMB

  Patient problems: Joint Laxity; Pain

  MAUDE report 24616229 ↗
• MalfunctionFeb 11, 2026Migration

  SUBJECT ID: (B)(6) STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR IMPLANT SHIFT DEVICE RELATED: CASUAL RELATIONSHIP (HUMERAL STEMLESS IMPLANT: YES) PROCEDURE RELATED: POSSIBLE DATE OF EVENT: 26 JAN 2026 DATE OF IMPLANT: (B)(6) 2025 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: OBSERVATION. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550011240 LOT NUMBER: 66451 COMPONENT TYPE: BASEPLATE DESCRIPTION: INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS. CATALOG NUMBER: 550035600 LOT NUMBER: 237381 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM. CATALOG NUMBER: 550310035 LOT NUMBER: 229426 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM LOCKING SCREW 35MM. CATALOG NUMBER: 550310025 LOT NUMBER: 233600 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM LOCKING SCREW 25MM. CATALOG NUMBER: 550310035 LOT NUMBER: 223956 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE SHOULDER SYSTEM LOCKING SCREW 35MM. CATALOG NUMBER: 550540008 LOT NUMBER: 333136 COMPONENT TYPE: GLENOSPHERE DESCRIPTION: INHANCE SHOULDER SYSTEM GLENOSPHERE Ø40+8MM. CATALOG NUMBER: 520000044 LOT NUMBER:

  Patient problems: Insufficient Information

  MAUDE report 24313190 ↗
• MalfunctionFeb 11, 2026Migration

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR IMPLANT SHIFT DEVICE RELATED: CASUAL RELATIONSHIP (HUMERAL STEMLESS IMPLANT: YES) PROCEDURE RELATED: POSSIBLE DATE OF EVENT: 26 JAN 2026 DATE OF IMPLANT: (B)(6) 2025 DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: OBSERVATION. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550011240 LOT NUMBER: 66451 COMPONENT TYPE: BASEPLATE DESCRIPTION: ENHANCE SHOULDER SYSTEM MODULAR UNIT PLATFORM BASEPLATE SMALL Ø24MM CEMENTLESS CATALOG NUMBER: 550035600 LOT NUMBER: 237381 COMPONENT TYPE: SCREW DESCRIPTION: ENHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 35MM CATALOG NUMBER: 550310035 LOT NUMBER: 229426 COMPONENT TYPE: SCREW DESCRIPTION: ENHANCE SHOULDER SYSTEM LOCKING SCREW 35MM CATALOG NUMBER: 550310025 LOT NUMBER: 233600 COMPONENT TYPE: SCREW DESCRIPTION: ENHANCE SHOULDER SYSTEM LOCKING SCREW 25MM CATALOG NUMBER: 550310035 LOT NUMBER: 223956 COMPONENT TYPE: SCREW DESCRIPTION: ENHANCE SHOULDER SYSTEM LOCKING SCREW 35MM CATALOG NUMBER: 550540008 LOT NUMBER: 333136 COMPONENT TYPE: GLENOSPHERE DESCRIPTION: ENHANCE SHOULDER SYSTEM GLENOSPHERE Ø40+8MM CATALOG NUMBER: 520000044 LOT NUMBER: 6598

  Patient problems: Insufficient Information

  MAUDE report 24313129 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). 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 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 24043065 ↗
• MalfunctionDec 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT PROCEDURE IT WAS OBSERVE THAT THE LOCKING SCREW BROKE DURING INSERTION. IT WAS REPORTED THAT WHEN THE SURGEON WAS INSERTING THE DEVICE INTO SOMEWHAT SCLEROTIC BONE IN THE GLENOID, SCREW HEAD SHEARED OFF. IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO REMOVE THE SHAFT OF THE BROKEN SCREW BUT WAS UNSUCCESSFUL IN DOING SO. IT WAS REPORTED THAT THERE WAS A 30-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO REPORTED CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23829448 ↗
• MalfunctionJun 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE INHANCE SHOULDER REPLACEMENT 35MM LOCKING SCREW HEAD BROKE OFF. THE REMAINING SCREW HAD TO BE BURRED DOWN BELOW THE METAGLEN SO THE GLENOSHERE COULD BE INSERTED. APPROXIMATELY 2/3 OF THE SCREW IS STILL WELL FIXED IN BONE. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Foreign Body In Patient

  MAUDE report 22227552 ↗
• MalfunctionMar 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE WHILE TRYING TO INSERT A PERIPHERAL LOCKING SCREW INTO THE BASEPLATE IN A PATIENT WITH HARD BONE, THE HEAD OF THE LOCKING SCREW BROKE OFF. ALL PIECES WERE RETRIEVED AND SURGICAL TIME WAS EXTENDED BY ROUGHLY 20 MINUTES WHILE THE REMAINING SEGMENT OF THE SCREW WAS REMOVED. A NEW BASEPLATE AND SCREWS WERE IMPLANTED AND THE PROCEDURE CONTINUED WITHOUT INCIDENT. NO ADVERSE CONSEQUENCES FOR THE PATIENT OCCURRED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536211 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS REVISED ON (B)(6) 2024 DUE TO PROBABLE INFECTION. ORIGINAL IMPLANT DATE WAS (B)(6) 2023

  Patient problems: Unspecified Infection

  MAUDE report 20496968 ↗
• MalfunctionOct 3, 2024Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED: THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT HARM TO THE EVENT. THE SCREW BROKE IN TWO PIECES. THE SCREWDRIVER WAS NOT STRIPPED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20364160 ↗