INHANCE 6200-48-170Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295539230), received between Jun 30, 2023 and Sep 22, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Break” (27 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  It was reported that during a Shoulder Repair surgery, the tabs on the humeral head trials broke off and they could not clip in the adapter trial.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849764 ↗
• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240734 ↗
• MalfunctionApr 28, 2026Break; Detachment of Device or Device Component

  IT WAS NOTICED WHILE TRIALING THE HEAD THAT SEVERAL OF THE PRONGS ON THE INNER PORTION OF THE TRIAL WERE BROKEN/MISSING. THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016402 ↗
• MalfunctionMar 18, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 48.5X17 HEAD TRIAL HAD TABS THAT WERE BROKEN, SO THE HUMERAL PIN GUIDE WOULD NOT STAY ENGAGED IN THE HEAD TRIAL. DR ASKED THAT HE GET THE HEAD TRIAL REPLACED. ALSO, THE CONVEX IMPACTOR TIP THREAD WAS STRIPPED OUT AND IT WOULD NOT STAY ENGAGED ON THE IMPACTOR HANDLE. DR ASKED THAT HE ALSO HAVE THAT REPLACED. ALL BROKEN PIECES WERE RETRIEVED AND NO DELAYS OR ADVERSE EVENTS TOOK PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634763 ↗
• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT HUMERAL HEAD TRIAL WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498117 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT INSIDE THE 48.5 X 17 TRIAL HEAD BROKE WHEN TAKING OUT THE OFFSET TRIAL ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236264 ↗
• MalfunctionJan 20, 2026Break

  IT WAS REPORTED THAT THE 48.5 X 17 NUMERAL HEAD TRIAL ADAPTOR PIECES ON THE INSIDE ARE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24120459 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT THE FLUTES OF THE HEAD BROKE DURING NORMAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24060889 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT WHILE WORKING WITH DR. (B)(6) AND SCRUB TECH ACTIVITY LEVEL - YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888168 ↗
• MalfunctionDec 18, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT TABS WITHIN THE HEAD TRIAL WERE BROKEN, MAKING IT DIFFICULT FOR THE TRIAL ADAPTER TO STAY ENGAGED IN THE HEAD TRIAL. DR ASKED THAT I HAVE IT REPLACED. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL - YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838661 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT THE 48X17.5 HUMERAL TRIAL WAS BROKEN DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745808 ↗
• MalfunctionNov 10, 2025Break; Break

  IT WAS REPORTED THAT DURING IMPACTION OF THE STEM, THE STEM INSERTER WAS CRACKED. THERE WERE NO PIECES LEFT BEHIND, NO HARM TO THE PATIENT, NO DELAY IN THE CASE. DURING TRIALING THE INNER PLASTIC CLIPS SNAPPED. NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512924 ↗
• MalfunctionAug 1, 2025Break; Break

  IT WAS REPORTED THAT UPON INSPECTION OF TRAY ITS WAS NOTED THAT THE LOCKING TEETH ON THE 48.5X17 HEADS WERE BROKE OFF ALSO THAT THE GLENOID INSERTER TIP WAS CROSSED THREADED AND WILL NOT THREAD ONTO THE HANDLE. THERE WAS NO DELAY TO CASE AND NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686865 ↗
• MalfunctionJul 18, 2025Crack; Crack

  IT WAS REPORTED THAT OFFSET TRIAL ADAPTER AND HUMERAL HEAD TRIAL WERE DISCOVERED BROKEN INTO MULTIPLE PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22544665 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT THE TRIALS HAVE BROKEN PARTS ON THE BOTTOM, AND THE GLENOSPHERE TIP WAS INTERNALLY STRIPPED. THE EVENT DID NOT HAPPENED DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357153 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTATION BROKE FROM THE SET. IT WAS NOTICED BEFORE THE CASE. A NEW SET WAS BROUGHT TO NOT DELAY THE CASE. THERE WAS NO DELAY. NO BROKEN PIECES LEFT ON FIELD OR PATIENT. NO SURGEON COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088729 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT THE TRIALS MUST HAVE BEEN DAMAGED IN A PREVIOUS CASE. THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995794 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT WHEN ASSEMBLING THE TRIALS, THE SCRUB TECH NOTED THAT BOTH THE TRIAL HEAD AND OFFSET TAPER ADAPTER HAD ABOUT 1/2 OF THE LOCKING TABS ON THE HEAD BROKEN OFF. ON THE ADAPTER, THE AREA THAT SNAPS THE ADAPTER TO THE HEAD WAS BROKEN OFF. NEITHER TRIAL WAS USED ON THE PATIENT. THE TRIALS MUST HAVE BEEN DAMAGED IN A PREVIOUS CASE. NO TIME LOST AND ALL PIECES WERE ACCOUNTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992665 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT THE HEAD TRIAL WAS BROKEN. UNKNOWN SURGICAL DELAY. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274789 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT WHEN ADJUSTING THE TRIAL ADAPTER, TWO PLASTIC TABS BROKE OFF THE 54X19 HEAD TRIAL. NO DELAYS OR ADVERSE EVENTS TOOK PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069240 ↗
• MalfunctionOct 15, 2024Crack; Crack

  IT WAS REPORTED THAT UPON INSPECTION, THE FOLLOWING PARTS WERE FOUND DAMAGED. INHANCE GLENO INSERTER - BAD THREADS X7; INHANCE OFFSET TAPER ADAPT - CRACKED X2; INHANCE HUMERAL HEAD TRIAL - CRACKED; INHANCE GLENO EXTRACTOR - BAD THREADS; INHANCE STEM INSERTER - CRACKED X2. DURING MANUFACTURER'S INVESTIGATION OF THE THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE DEVICE DID NOT FOUND SIGNS OF CRACKING, HOWEVER THE HUMERAL HEAD TRIAL 48.5X17 HAS FOUR INTERNAL TABS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452596 ↗
• MalfunctionSep 30, 2024Break; Break

  IT WAS REPORTED THAT THE TRIAL BROKE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334621 ↗
• MalfunctionJul 17, 2024Break; Break

  IT WAS REPORTED THAT THE FINS SNAPPED OFF ON UNDERSIDE OF TRIAL HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19759874 ↗
• MalfunctionMay 14, 2024Break; Break

  RETENTION TABS SNAPPED OFF POST OP AFTER DECONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312502 ↗
• MalfunctionApr 26, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER RESPECTING THE HUMERAL HEAD AND IMPLANTING THE TRIAL STEM THE SURGEON SIZED THE HEAD RESECTION, SNAPPED THE ADAPTER AT C AND TURNED CLOCKWISE TO H OFFSET. WHEN WENT TO PLACE FROM TRIALING IT CAME LOOSE. WHEN BROUGHT TO BACK TABLE IT WAS NOTICED SMALL TEETH LIKE PIECES INSIDE OF HEAD WERE SNAPPED OFF. THE PROCESS WAS DONE AGAIN WITH ONE SIZE UP HUMERAL HEAD, THE SAME THING HAPPENED. HE THEN MOVED ONTO PREPARING THE GLENOID AND ONCE PREPARED HE DECIDE ON A REVERSE. HE HAD NO ISSUES WITH BASEPLATE OR TRIAL GLENOSPHERE. HE ALIGNED THE LINES ON THE +0 SHELL TRIAL AND THE 40+0R POLY AND AN AUDIBLE SNAP WAS HEARD. HE THEN PLACED THAT CONSTRUCT ON THE STEM AND THE POLY WOULD NOT STAY SNAPPED IN PLACE AND DISSOCIATED ONCE THROUGH TRIALING THROUGH ROM THUS CREATING A MINOR DELAY IN SURGICAL PROCEDURE. DOCTOR WAS SATISFIED WITH OVERALL RANGE OF MOTION AND X-RAYS OF OVERALL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19190443 ↗