INHANCE 5503-00-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295546849), received between Oct 31, 2022 and Mar 17, 2026 — classified as 1 injury, 4 malfunctions.

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

• 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 24616505 ↗
• MalfunctionDec 28, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SCREW PENETRATED THE MODULAR BASEPLATE DURING REVERSE SHOULDER INHANCE PROCEDURE. 15MIN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16062306 ↗
• MalfunctionDec 20, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON HAD ANOTHER SCREW GO THROUGH A BASEPLATE. THE INCIDENT INVOLVED A SELF-DRILLING SCREW AND A LARGE BASEPLATE. HE DID NOT USE A NON-LOCKING SCREW PRIOR TO USING THE SELF-DRILLING SCREW. WHEN THINKING ABOUT WHY THE SURGEON IS THE ONLY ONE SEEING THIS ISSUE, IT WAS HYPOTHESIZED THAT HE IS DAMAGING THE THREADS WITH THE BASEPLATE IMPACTOR HANDLE WHEN IT IS USED WITHOUT THE INSERTER ROD. THE SURGEON'S TECHNIQUE IS AS FOLLOWS: INSERT THE BASEPLATE WITH THE BASEPLATE INSERTER ROD, WITHOUT THE IMPACTOR HANDLE ASSEMBLED REMOVE THE BASEPLATE INSERTER ROD AND USE THE IMPACTOR HANDLE TO SEAT THE BASEPLATE. OTHER SURGEONS REPORT THAT THEY USE THE ENTIRE CONSTRUCT (IMPACTOR HANDLE AND ROD) TO SEAT THE GLENOID. ANOTHER SURGEON ONLY USES THE IMPACTOR ROD TO SEAT THE GLENOID. THIS IS A SHOULDER RECONSTRUCTION INHANCE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16013998 ↗
• MalfunctionOct 31, 2022Difficult to Insert; Difficult to Insert

  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 15698614 ↗
• MalfunctionOct 31, 2022Difficult to Insert; Difficult to Insert

  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 15698612 ↗