Shoulder System 04.01.0169Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 07630040706568), received between Dec 5, 2018 and Jul 14, 2026 — classified as 36 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2026Device Dislodged or Dislocated

  THE PATIENT HAD PAIN DUE TO THE GLENOSPHERE DISASSOCIATING FROM THE BASEPLATE AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA OR A FALL. AT ABOUT 2 MONTHS POST PRIMARY THE SURGEON REVISED THE GLENOSPHERE TO A SAME SIZE GLENOSPHERE.THE WIRE GUIDE WAS NOT USED DURING THE PRIMARY TO ASSEMBLE THE GLENOSPHERE TO THE BASEPLATE. THE CORRECT TORQUE SCREWDRIVER WAS USED TO TIGHTEN THE GLENOSPHERE SCREW.THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 25813736 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  AT6 YEARS 5 MONTHS FROM PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO IMPINGEMENT CAUSED BY SCAPULA NOTCHING. THE SURGEON REVISED THE GLENOSPHERE - D 36X24.5 TO A LAT. GLENOSPHERE 42XD 24.5 TO REDUCE IMPINGEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Impingement

  MAUDE report 24762671 ↗
• InjuryJan 29, 2026Device Dislodged or Dislocated

  AT ABOUT 3 YEARS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE LINER AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24208601 ↗
• InjuryNov 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  FOUR MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED BOTH THE LINER AND THE GLENOSPHERE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23478279 ↗
• InjuryAug 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH FROM THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22903700 ↗
• MalfunctionJun 25, 2025Difficult to Insert; Difficult to Insert

  WHEN CONNECTION THE GLENOSPHERE TO THE BASEPLATE, IT DID NOT FULLY SEAT. THE GLENOSPHERE SCREW LOCKED APPROXIMATELY 2-3 MM BEFORE FULLY ENGAGING IN THE BASEPLATE. THE GLENOSPHERE WAS REINSERTED AFTER CLEANING AROUND THE BASEPLATE, BUT THE SITUATION DID NOT CHANGE. WHEN RECHECKING THE SCREW HEAD, THE TIP OF THE SCREW SHOWED SILVER WEAR MARKS. SO, THE SCREW ALONE WAS INSERTED. THEN, A GRINDING NOISE WAS HEARD, SO IT WAS REPLACED WITH A NEW SCREW (REF. 04.01.0177, LOT: 2418605). THE GLENOSPHERE GUIDE (REF 04.01.10.0432) WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE 30 MINUTES DELAY TO INSERT THE SCREW INTO THE BASEPLATE (TOT TIME 2.5 HOURS).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22326365 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 MONTHS FROM PRIMARY, DURING POSTOP VISIT, THE SURGEON DETECTED AN ACROMION FRACTURE AND PRESCRIBED PHYSIOTHERAPY AND ANALGESIC TO THE PATIENT. NO REVISION PLANNED.

  Patient problems: Bone Fracture(s)

  MAUDE report 22209610 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACROMION FRACTURE DETECTED 7 MONTHS POST-OP. PHYSIOTHERAPY HAS BEEN PRESCRIBED AND REVISION SURGERY IS NOT PLANNED.

  Patient problems: Bone Fracture(s)

  MAUDE report 22025986 ↗
• InjuryMar 19, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21642249 ↗
• InjuryMar 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN AFTER FALLING OUT OF BED THAT RESULTED IN A LOOSE BASEPLATE. THE SURGEON REVISED THE METAPHYSIS, LINER, BASEPLATE, PERIPHERAL SCREWS AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE GLENOSPHERE FROM THE LINER. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 21585868 ↗
• InjuryOct 31, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20576919 ↗
• MalfunctionSep 11, 2024Difficult to Insert; Difficult to Insert

  THE FIXATION GLENOSPHERE SCREW AND THE GLENOSPHERE ROTATED AT THE SAME TIME WHILE TIGHTENING AND THE GLENOID BONE FRACTURED. IT'S UNKNOWN WHETHER THE FRACTURE OCCURRED DURING THE SEATING OF THE BASEPLATE OR THE GLENOSPHERE. BONE GRAFT USED TO COMPLETE THE SURGERY, 27MM BASEPLATE AND 36XØ27 GLENOSPHERE SUCCESSFULLY IMPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s)

  MAUDE report 20188176 ↗
• InjurySep 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 5 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE GLENOSPHERE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 20117926 ↗
• InjuryJun 28, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SHOULDER WAS MAKING A POPPING SOUND. THE SURGEON BELIEVES THERE WAS IMPINGEMENT BETWEEN THE GLENOSPHERE AND THE PATIENT'S BONY ANATOMY. THE SURGEON REVISED THE METAPHYSIS, LINER, AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 19632748 ↗
• InjuryJun 20, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON THE (B)(6) 2021. ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION (PROPIONI-BACTERIUM). ALL COMPONENTS WERE SUCCESSFULLY REVISED. REIMPLANTATION OF NEW REVERSE SHOULDER COMPONENTS, BONE GRAFT AND LONG HUMERAL STEM. ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY DUE TO LINER-GLENOSPHERE DISLOCATION AND LOOSENING OF THE DIAPHYSIS. THE SURGEON EXPLANTED THE LONG HUMERAL STEM, THE METAPHYSIS, THE LINER AND THE GLENOSPHERE (TO TEST THE STABILITY OF THE BASEPLATE AND THE GRAFT). REIMPLANTATION OF A NEW LONG HUMERAL STEM (CEMENTED) WITH A NEW METAPHYSIS AND LINER +6MM (155 DEGREES) AND A LATERALIZED GLENOSPHERE.

  Patient problems: Joint Dislocation

  MAUDE report 19575477 ↗
• MalfunctionJun 14, 2024Difficult to Insert; Difficult to Insert

  IT WAS NOT POSSIBLE TO INSERT CORRECTLY THE SCREWS OF GLENOSPHERE AND METAPHYSIS DURING SURGERY. THE EVENT WAS LIKELY DUE TO SOFT TISSUE INTERPOSED BETWEEN BASEPLATE/GLENOSPHERE AND MISSING USE OF THE GLENOSPHERE GUIDE. FOR METAPHYSIS, IT WAS POSSIBLE THAT THE METAPHYSIS SCREW WAS DEFORMED BECAUSE IT WAS INSERTED WITH AN ANGLE AT FIRST. THE SURGEON REMOVED BONE AND SOFT TISSUE AROUND THE COMPONENTS, TAKE 2 SCREWS FROM DIFFERENT IMPLANTS, AND COMPLETED THE SURGERY SUCCESSFULLY. 1 HOUR OF DELAY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19535374 ↗
• InjuryJan 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY FOR SHOULDER LUXATION 4 DAYS AFTER PRIMARY. GLENOSPHERE AND LINER REVISED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18483998 ↗
• InjuryDec 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO SHOULDER LUXATION WAS PERFORMED ABOUT 3 MONTHS AFTER THE PREVIOUS REVISION SURGERY. THE PATIENT WAS PREVIOUSLY REVISED DUE TO A TRAUMATIC EVENT THAT CAUSED A BONE FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18244674 ↗
• InjurySep 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AND 2 WEEKS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE METAPHYSIS, LINER AND GLENOSOPHERE.

  Patient problems: Medical device site infection

  MAUDE report 17780187 ↗
• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 MONTHS FROM PRIMARY IT WAS OBSERVED THAT THE BASEPLATE AND GLENOSPHERE WERE POSITIONED VERY SUPERIOR AND NEEDED TO BE REVISED. THE CAUSE OF THIS IS UNKNOWN. THE SURGEON REVISED THE BASEPLATE AND GLENOSPHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15779271 ↗
• InjuryOct 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT LUXATED THE JOINT DURING REHABILITATION. THE SURGEON REVISED THE LINER AND THE GLENOSPHERE (WITH A BIGGER ONE).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15689955 ↗
• InjurySep 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE GLENOSPHERE FROM THE LINER. THE CAUSE OF THE DISLOCATION IS UNKNOWN. AT 5 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE GLENOSPHERE AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15469319 ↗
• InjuryAug 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY AT ABOUT 2 MONTHS FROM PRIMARY FOR SHOULDER DISLOCATION (GLENOSPHERE - LINER). SIGNS OF METALLOSIS CAUSED BY THE DISLOCATION FOUND IN THE JOINT. THE SURGEON REVISED GLENOSPHERE, METHAPHYSIS AND LINER SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 15283226 ↗
• InjuryJun 24, 2022Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED DUE TO JOINT LUXATION 1 MONTH AFTER THE PRIMARY SURGERY. ONLY REPLACED INSERT WITH SAME THICKNESS BUT 155° BECAUSE THE ARTICULATION REMAINED VERY STABLE ONCE REDUCED.

  Patient problems: Joint Dislocation

  MAUDE report 14801073 ↗
• InjuryApr 26, 2021Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED DUE TO RECURRENT DISLOCATIONS. THE PATIENT HAS DEMENTIA AND IS NON-COMPLIANT, WHICH COULD BE THE REASON FOR THE REPETITIVE DISLOCATIONS. THE SURGEON PERFORMED A SALVAGE-HEMIARTHROPLASTY ON THE PATIENT ON (B)(6) 2021, 3 DAYS AFTER THE LAST REVISION SURGERY WHERE ONLY THE LINER WAS REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 11723776 ↗