INHANCE 6200-51-180Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295539254), received between Feb 16, 2022 and Sep 22, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 21 most recent of 21 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 50849777 ↗
• MalfunctionAug 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50523587 ↗
• MalfunctionAug 26, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50451902 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT THE 5 REVERSE HUMERAL TRIALS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24087153 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT 5 BROKEN REVERSE HUMERAL TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059801 ↗
• 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 23888180 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT PLASTIC PEGS ON BACKSIDE OF TRIAL SHELLS BROKE OFF DURING SURGERY. IT BROKE ON BACK TABLE DISASSEMBLING TRIALS, NOT IN A PATIENT. ALL PARTS WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840747 ↗
• 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 22088735 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT MEDIAL SIDE OF HUMERAL HEAD TRIAL CHIPPED OFF WHEN TAKING APART ON THE BACK TABLE. DOE:(B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045086 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT WHILE GOING THROUGH INSTRUMENTS TO TURN THEM OVER FOR CASES, IT WAS NOTICED THAT THESE INSTRUMENTS WERE ALL BROKEN AND NEEDED TO BE REPLACED. THERE WERE NO DELAYS OR ADVERSE EVENTS THAT TOOK PLACE FOR ANY OF THE DOCTOR'S CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881418 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT TRIAL HEAD BROKE. IT BROKE ON REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 21748843 ↗
• 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 21069213 ↗
• MalfunctionSep 26, 2024Break; Break

  IT WAS REPORTED THAT THE SALES CONSULTANT NOTICED THAT THE PLASTIC TABS INSIDE OF HEAD HAD BROKEN OFF. REMOVING FROM USE. IT DID NOT HAPPENED DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20316998 ↗
• 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 19190438 ↗
• MalfunctionMar 11, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED. A. WHICH PART OF THE INSTRUMENT BROKE? THE PLASTIC CENTER TABS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874158 ↗
• MalfunctionFeb 19, 2024Break; Break

  IT WAS REPORTED THAT THE TABS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730126 ↗
• MalfunctionFeb 13, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED: A. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? -NO ADVERSE CONSEQUENCES. B. DID THE EVENT OCCUR DURING THE SURGERY? IF YES, WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? -NO SURGICAL DELAY. C. WERE THERE PIECES BROKEN OFF FROM THE INSTRUMENT? IF YES, DID IT BREAK INTO 2 OR MORE PIECES? - NO PIECES BROKEN OFF. D. WHAT PART OF THE INSTRUMENTS WERE BROKEN? -HUMERAL HEAD TRIALS BROKE ON THE INSIDE WHERE ADAPTER TRIAL FITS, VERSION INDICATOR PLASTIC PART CRACKED, SIZER AND GLENOID TRIALS CRACKED, INSERTER TIP THREADS WORN. E. WERE ALL PIECES OF THE BROKEN INSTRUMENT RETRIEVED FROM THE PATIENT? -ALL PIECES RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693903 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT AFTER THE CASE, THE STERILE PROCESSING TECH NOTICED THE HUMERAL TRIAL WAS STILL PUT TOGETHER WHEN IT CAME TO DECON. WHEN THE TECH TRIED TO REMOVE THE OFFSET TAPER SHE NOTICED THAT 2 OF THE TABS ON THE 51X18 TRIAL BROKE OFF AND WENT DOWN THE DRAIN, IT DID BREAK INTO MULTIPLE PIECES. THIS HAPPENED POST OP. SO THERE WAS NO NEGATIVE IMPACT TO THE PATIENT, NOR WAS SURGERY TIME EXTENDED DUE TO THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18073622 ↗
• MalfunctionSep 5, 2023Break; Break

  IT WAS REPORTED THAT THE REP NOTICED THAT THE INTERNAL PLASTIC BARBS OF THE TRIAL HEAD HAD CRACKED OFF DURING WASHING. DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17685919 ↗
• MalfunctionMar 1, 2022Break; Break

  INTERNAL CRACKED WHILE ADJUSTING THE TRIAL OFFSET TAPER ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13637471 ↗
• MalfunctionFeb 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A SALES CALL AND SAWBONES DEMO ONE OF THE HEAD TRIALS IN THE ENHANCE SET WAS FRACTURED. THIS OCCURRED DURING AN OFFICE VISIT AND DID NOT IMPACT PATIENT CARE IN ANY WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13542933 ↗