REUNION 5901-1168Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 07613327101027), received between Nov 30, 2017 and Sep 18, 2025 — classified as 2 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Fracture” (31 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE THREADED TIP OF THE GLENOSPHERE INSERTION HANDLE BROKE OFF DURING INSERTION OF THE GLENOSPHERE. THE TIP REMAINED IN THE GLENOSPHERE AND THEREFORE REMAINS IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23085654 ↗
• MalfunctionJun 14, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A PRIMARY PROCEDURE FOR RIGHT TOTAL SHOULDER, ON IMPACTION OF THE GLENOSPHERE, THE THREADED TIP OF THE IMPACTOR BROKE AND FELL INTO THE PATIENT. SURGEON REMOVED THE BROKEN PORTION. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AS IMPACTION WAS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691267 ↗
• InjuryMar 21, 2022Break; Break

  AS REPORTED: "IN AN RSA PROCEDURE THE GLENOSPHERE WAS LOADED ONTO THE IMPACTOR HANDLE AND THREADED ON. WHILE SURGEON WAS IMPACTING THE GLENOSPHERE DID NOT SEAT ALL THE WAY AND THE THREADS BROKE OFF OF IMPACTOR AND WAS STUCK IN THE IMPLANT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13842483 ↗
• MalfunctionSep 3, 2021Fracture; Fracture

  IT WAS REPORTED THAT WHILE IMPACTING THE GLENOSPHERE IMPACTOR/HOLDER THE TIP OF THE IMPACTOR BROKE OFF INTO THE GLENOSPHERE. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN TIP, AND LEFT IT INSIDE THE GLENOSPHERE. THE SURGEON FINISHED IMPACTING WITH THE SECONDARY IMPACTOR. NO ADVERSE CONSEQUENCES TO THE PATIENT OR CLINICALLY SIGNIFICANT SURGICAL DELAY WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12425619 ↗
• MalfunctionApr 26, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A PRIMARY RIGHT REVERSE SHOULDER PROCEDURE, THE GLENOSPHERE IMPACTOR THREADED TIP BROKE OFF IN THE IMPLANT IN IMPACTION. THE BROKEN PIECES WERE REMOVED AND A BACKUP DEVICE WAS USED TO FINISH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11728971 ↗
• MalfunctionApr 13, 2021Break; Break

  IT WAS REPORTED: "PRIMARY PROCEDURE, RIGHT REVERSE SHOULDER. IT WAS REPORTED THAT THE THREADED PORTION OF THE GLENOSPHERE HOLDER/ IMPACTOR BROKE OFF IN THE GLENOSPHERE. THE BROKEN PORTION WAS REMOVED AND A SECOND INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH A SURGICAL DELAY OF LESS THAN 5 MINUTES. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655431 ↗
• MalfunctionMar 3, 2021Fracture; Fracture

  PRIMARY PROCEDURE, RIGHT REVERSE TOTAL SHOULDER. IT WAS REPORTED THAT WHILE POSITIONING THE GLENOSPHERE, THE THREADED TIP OF THE INSERTER BROKE OFF IN THE GLENOSPHERE. REP CONFIRMED THERE WAS NO USE OF A MALLET ON THE INSERTER. SURGEON WAS ABLE TO REMOVE THE THREADED PORTION, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 5-10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404930 ↗
• MalfunctionFeb 10, 2021Fracture; Fracture

  AS REPORTED: "THE SURGEON WAS IMPLANTING THE GLENOSPHERE WITH THE INSERTER BROKE AT THE TIP LEAVING A SMALL PART OF IT IN THE ALREADY IMPACTED GLENOSPHERE. THE SURGEON FELT IT WAS SAFE TO LEAVE IT AND SAID IT WILL DO MORE HARM TRYING TO REMOVE IT. THE GLENOSPHERE WAS THEN [ILLEGIBLE] AND HE FINISHED THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11309140 ↗
• MalfunctionFeb 9, 2021Break; Break

  AS REPORTED: "PRIMARY PROCEDURE, LEFT REVERSE SHOULDER. IT WAS REPORTED THAT THE THREADED PORTION OF THE INSERTER BROKE OFF IN THE GLENOSPHERE. THE IMPLANT WAS REMOVED AND A SECOND IMPLANT WAS USED TO COMPLETE SURGERY SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 30 MINUTES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11305292 ↗
• MalfunctionNov 9, 2020Fracture; Fracture

  AS REPORTED: "DR IMPACTED THE GLENOSPHERE INSERTER WHEN THE GLENOSPHERE WAS NOT ON THE BASEPLATE. TIP BROKE OFF AND WE WERE ABLE TO TAKE OUT THE TIP. IMPACTED THE GLENOSPHERE AND THE CASE WENT FINE. SURGEON ACKNOWLEDGED HE WAS NOT ON THE BASEPLATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10813449 ↗
• MalfunctionOct 1, 2020Fracture; Fracture

  PRIMARY PROCEDURE, LEFT REVERSE SHOULDER. IT WAS REPORTED THAT ON IMPACTION, THE THREADED PORTION OF THE GLENOSPHERE INSERTER BROKE OFF IN THE GLENOSPHERE. THE GLENOSPHERE WAS REMOVED AND A SECOND GLENOSPHERE WAS IMPLANTED USING A SECOND INSERTER. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10 MINUTES. THE GLENOSPHERE WITH THE BROKEN THREADED PORTION WAS DISPOSED BY HOSPITAL STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10617249 ↗
• MalfunctionAug 21, 2020Fracture; Fracture

  PRIMARY PROCEDURE, RIGHT REVERSE SHOULDER. IT WAS REPORTED THAT ON IMPACTION, THE THREADS OF THE GLENOSPHERE IMPACTOR BROKE OFF IN THE IMPLANT. THE THREADS WERE REMOVED AND A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 2 MINUTES. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10436756 ↗
• MalfunctionAug 7, 2020Fracture; Fracture

  AS REPORTED: "GLENOSPHERE INSERTER BROKE DURING IMPACTION OF GLENOSPHERE. GLENOSPHERE SCREWS INTO IMPACTOR VIA SMALL THREADED SCREW. SCREW TIP BROKE OFF INSIDE THE GLENOSPHERE AND UNABLE TO REMOVE. GLENOSPHERE WAS SEATED, NO MORE ACTION NEEDED."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10380026 ↗
• MalfunctionJul 16, 2020Fracture; Fracture

  PRIMARY PROCEDURE, LEFT REVERSE SHOULDER. IT WAS REPORTED THAT UPON IMPACTION, THE THREADED PORTION OF THE GLENOSPHERE HOLDER/ IMPACTOR BROKE OFF IN THE GLENOSPHERE. THE THREADED PORTION WAS REMOVED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10286511 ↗
• MalfunctionJun 23, 2020Fracture; Fracture

  PRIMARY PROCEDURE, RIGHT REVERSE TOTAL SHOULDER. IT WAS REPORTED THAT ON IMPACTION, THE THREADED TIP OF THE GLENOSPHERE IMPACTOR BROKE IN THE GLENOSPHERE. SURGEON REPORTED HE HAD BEEN IMPACTING AT AN ANGLE DUE TO PATIENT ANATOMY. GLENOSPHERE WAS BROUGHT TO THE BACK TABLE, THE THREADED PORTION WAS REMOVED. THE LONG GRAY SLEEVE WAS REMOVED FROM THE IMPACTOR, AND THE BROKEN IMPACTOR WAS USED TO COMPLETE THE CASE SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10 MINUTES. THE REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10186682 ↗
• MalfunctionJun 23, 2020Fracture; Fracture

  PRIMARY PROCEDURE, LEFT REVERSE TOTAL SHOULDER. IT WAS REPORTED THAT THE THREADED PORTION OF THE GLENOSPHERE IMPACTOR BROKE INSIDE THE IMPLANT. AFTER ASSESSMENT, THE BROKEN PORTION DID NOT APPEAR TO BE SHARP OR SITTING PROUD. SURGEON DECIDED TO LEAVE THE BROKEN PORTION IN THE PATIENT. SURGERY COMPLETED SUCCESSFULLY WITH A DELAY OF UNDER 20 SECONDS. THE REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10186547 ↗
• MalfunctionApr 3, 2020Fracture; Fracture

  AS REPORTED: "THE GLENOSPHERE IMPACTOR THREADS BROKE OFF IN THE GLENOSPHERE. IT BROKE OFF AT THE TIME OF INSERTION." ADDITIONALLY REPORTED: "THE IMPACTOR THREADS ARE IN THE GLENOSPHERE AND WERE NOT REMOVED."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9924739 ↗
• MalfunctionMar 14, 2020Fracture; Fracture

  PRIMARY PROCEDURE, RIGHT REVERSE SHOULDER. IT WAS REPORTED THAT UPON IMPACTION, THE THREADED PORTION OF THE GLENOSPHERE INSERTER BROKE OFF INSIDE THE GLENOSPHERE. THE BROKEN PORTION WAS NOT SITTING PROUD, AND COULD NOT BE RETRIEVED FROM THE GLENOSPHERE. THE SURGEON ELECTED TO LEAVE THE BROKEN PIECE INSIDE THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 5 MINUTES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9832839 ↗
• MalfunctionMar 11, 2020Fracture; Fracture

  A SALES REP REPORTED: DURING A REVERSE SHOULDER PROCEDURE, THE DEVICE BROKE WHILE IMPACTING THE GLENOSPHERE. ADDITIONALLY REPORTED: DEBRIS WAS RETAINED IN THE THREADS OF THE GLENOSPHERE. PROCEDURE WAS COMPLETED WITH SECONDARY IMPACTOR.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9821050 ↗
• MalfunctionFeb 27, 2020Fracture; Fracture

  SURGEON WAS IMPLANTING GLENOSPHERE, AS HE IMPACTED WITH MALLET INSTRUMENT SCREW/ THREADED PART BROKE IN MIDDLE OF THREADS WHERE GLENOSPHERE DOME ENDS. SURGEON WAS TORQUING ON INSTRUMENT A LITTLE TOO MUCH. A DELAY IN CASE FLOW WAS REPORTED (LENGTH UNKNOWN).

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9766378 ↗
• MalfunctionFeb 25, 2020Fracture; Fracture

  INTRA OP, DURING IMPACTION OF THE GLENOSPHERE THE TIP OF THE SCREW BROKE OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9751887 ↗
• MalfunctionFeb 18, 2020Fracture; Fracture

  PRIMARY REVERSE SHOULDER PROCEDURE. IT WAS REPORTED THAT WHILE IMPACTING THE GLENOSPHERE WITH SLIGHTLY EXCESSIVE FORCE, THE THREADED PORTION OF THE HOLDER/ INSERTER BROKE OFF IN THE GLENOSPHERE. THE THREADS WERE ABLE TO BE EXTRACTED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9721599 ↗
• MalfunctionFeb 3, 2020Fracture; Fracture

  PRIMARY PROCEDURE, LEFT REVERSE SHOULDER. IT WAS REPORTED THAT UPON IMPACTION OF THE GLENOSPHERE, THE THREADED PORTION OF THE HOLDER/ IMPACTOR BROKE OFF IN THE GLENOSPHERE. THE BROKEN THREADED PORTION WAS ABLE TO BE REMOVED FROM THE GLENOSPHERE AND DISPOSED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9659648 ↗
• MalfunctionJan 13, 2020Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  GLENOSPHERE INSERTER WAS BENT FROM PRIOR USE/ GENERAL WEAR AND TEAR FROM BEING IN THE LOANER SET. THE TIP BROKE OFF WHEN TRYING TO THREAD/UNTHREAD IT ON TO THE GLENOSPHERE. YOU COULD SEE THAT IT WAS BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9584523 ↗
• MalfunctionJan 6, 2020Fracture; Fracture

  PRIMARY PROCEDURE, RIGHT REVERSE SHOULDER. IT WAS REPORTED THAT UPON IMPACTION, THE THREADED PORTION OF THE GLENOSPHERE IMPACTOR BROKE OFF IN THE GLENOSPHERE. AS THE BROKEN THREADED PORTION WAS FLUSH WITH THE GLENOSPHERE, SURGEON ELECTED TO USE A SECOND NON-THREADED IMPACTOR TO FINISH IMPACTING THE GLENOSPHERE WITH THE BROKEN THREADED PORTION STILL IN IT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9555945 ↗