INHANCE 6500-11-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295547228), received between Jan 23, 2023 and May 4, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (12 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Material Deformation

  IT WAS REPORTED THAT THE IMPACTOR WAS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067849 ↗
• MalfunctionApr 30, 2026Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT THE INHANCE INSERTER HANDLE AND GLENOSPHERE INSERTER TIP WOULD NOT THREAD TOGETHER EASILY. THREADS MUST BE DAMAGED. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046861 ↗
• MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BASEPLATE INSERTER ROD AND HANDLE FRICTION WELDED TO SMALL BASEPLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750020 ↗
• MalfunctionDec 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR SHOULDER REPAIR IT WAS OBSERVED THAT THE INSERTER WAS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706694 ↗
• MalfunctionAug 14, 2025Material Deformation; Material Deformation

  TREADS ON T HANDLE FOR IMPACTING BASEPLATE HAVE CROSSED AND THE T HANDLE IS NO LONGER FUNCTIONING. THE TREADS ON THE T HANDLE ARE WORN DOWN. THERE IS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803155 ↗
• MalfunctionJul 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIECES ARE COLD WELDED TOGETHER. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378798 ↗
• MalfunctionJun 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY, PERFORMED BY THE SURGEON ON (B)(6) 2025, AT THE HOSPITAL THE ENHANCE BASEPLATE INSERTER ROD AND BASEPLATE INSERTER HANDLE BECAME FUSED TO THE BASEPLATE IMPLANT DURING IMPLANTATION. THE SURGEON WAS UNABLE TO DISENGAGE THE CONSTRUCT FROM THE IMPLANT, SO ENTIRE CONSTRUCT WAS REMOVED FROM PATIENT, AND NEW IMPLANT AND BACKUP INSTRUMENTS WERE USED TO COMPLETE THE CASE. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296484 ↗
• MalfunctionMar 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INHANCE BASEPLATE INSERTER ROD CROSS-THREADED INTO A DEFINITIVE BASEPLATE IMPLANT, AND COULD NOT BE SEPARATED. THE IMPLANT WASTED, AND INSERTER ROD USELESS. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. NEW INSTRUMENT SET AND NEW SMALL BASEPLATE WERE OPENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503588 ↗
• MalfunctionJan 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE HANDLES WERE STRIPPED.

  Patient problems: Insufficient Information

  MAUDE report 21223102 ↗
• MalfunctionJan 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE HANDLES WERE STRIPPED.

  Patient problems: Insufficient Information

  MAUDE report 21223018 ↗
• MalfunctionJan 14, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE INHANCE BASEPLATE INSERTER ROD WAS CROSS THREADED INTO A DEFINITIVE BASEPLATE IMPLANT AND COULDN'T SEPARATE THEM. ANOTHER SET OF INSTRUMENTS FOR A DIFFERENT BASEPLATE INSERTER ROD WAS OPENED TO PROCEED WITH THE PROCEDURE. THERE WAS A TWO MINUTES OF SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149162 ↗
• MalfunctionOct 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE THREADS ARE FAULTY IN BASEPLATE INSERTER/SMALL BASEPLATE. MADE IT IMPOSSIBLE TO REMOVE FROM BASEPLATE/BASEPLATE INSERTER HANDLE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514272 ↗
• MalfunctionOct 17, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE BASEPLATE ROD AND HANDLE WAS CROSS THREADED ON TO THE BASEPLATE THEN COLD WELDED AFTER IMPACTED. A SECOND BASEPLATE ROD WAS ATTEMPTED TO THREAD ON TO A SECOND GLENOSPHERE INSERTER TIP BUT THE ROD THREADS WERE WORN AND IT WOULDN¿T THREAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471745 ↗
• MalfunctionAug 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE SURGICAL DELAY LASTED ABOUT 4-5 MINUTES. THERE WERE NO REPORTS OF ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049597 ↗
• MalfunctionJul 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BASEPLATE HANDLE COULD NOT UNTHREAD FROM THE IMPLANT. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19805129 ↗
• MalfunctionApr 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 29MM INHANCE METAGLENE COMPONENT WOULD NOT RELEASES FROM THE INSERTER.

  Patient problems: Insufficient Information

  MAUDE report 19087264 ↗
• MalfunctionMar 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SURGEON COMPLAINED ABOUT THE THREADS ON BOTH ITEMS. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827318 ↗
• MalfunctionDec 6, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  THE DEVICES WERE REPORTED FOR AN UNKNOWN REASON/MALFUNCTION. THE EVENT DID NOT HAPPEN IN SURGERY. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE THREADED SHAFT OF THE BASEPLATE INSERTER HANDLE PRESENTS LIGHT SCRATCHES AND NICKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275013 ↗
• MalfunctionJan 23, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED: A. WERE THERE ANY PIECES BROKEN OFF FROM THE INSTRUMENT? IF YES, DID IT BREAK INTO TWO OR MORE PIECES? IT WAS NOT BROKEN INTO MULTIPLE PIECES. THE TIP WAS JUST CROSS-THREADED. IT WAS MORE SHAVINGS. B. PLEASE CLARIFY WHAT YOU MEAN BY DAMAGED FOR BASEPLATE INSERTER HANDLE? IS IT BROKEN INTO TWO PIECES, CRACKED, BENT, STRIPPED, WORN, CROSS-THREADED, OR ANY DEVICE INTERACTION? THE TIP OF THE INSTRUMENT IS EITHER STRIPPED OR CROSS-THREADED. IT WOULD NOT SCREW INTO THE BASEPLATE CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224237 ↗