Shoulder System 04.01.0120Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 07630040706278), received between Feb 9, 2018 and May 5, 2026 — classified as 40 injuries.

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. 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 40 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING SHOULDER INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE D 36/+3MM REVERSE HC LINER TO A D 36/+6 REVERSE CONSTRAINED LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 25077218 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  AT (B)(6) FROM PRIMARY, THE PATIENT CAME IN DUE TO RANGE OF MOTION PAIN AND THE CAUSE IS UNKNOWN. NO TRAUMA WAS INDICATED.NO IMPINGEMENT SUSPECTED OR NOTICED. BONE GRAFT WAS NOT USED IN THE PRIMARY SURGERY.THE SURGEON REVISED THE D 36/+3MM LINER AND IMPLANTED A D 36/+6MM LINER AT 155 DEGREES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 25039777 ↗
• InjuryMar 13, 2026Device Dislodged or Dislocated

  AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN ASSOCIATED WITH A DISLOCATION OF THE GLENOSPHERE AND LINER. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE GLENOSPHERE FROM A D 36 LAT TO A D 39 LAT AND THE LINER FROM A SIZE D 36/+3MM TO A SIZE D 39/+6MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24593593 ↗
• InjuryFeb 26, 2026Device Dislodged or Dislocated

  AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO A DISLOCATION OF THE HUMERUS AND GLENOSPHERE AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON PERFORMED A SWAP OF THE HC LINER D 36/+3 TO A CONSTRAINED E-CROSS D 36/+3 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24454891 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER 1 MONTH FROM THE PRIMARY THE PATIENT CAME IN REPORTING PAIN DUE TO DISLOCATION OF THE LINER FROM THE GLENOSPHERE THAT WAS CAUSED BY A FALL. THE SURGEON REVISED THE LINER, GLENOSPHERE, METAPHYSIS, AND DIAPHYSIS. THE DIAPHYSIS WAS REVISED BECAUSE THE SURGEON BELIEVED THE BASEPLATE MAY HAVE BEEN POSITIONED TOO ANTEVERTED DURING THE PRIMARY PROCEDURE. SINCE IT WAS A GRS BASEPLATE, HE PREFERRED NOT TO MANIPULATE IT AND INSTEAD DECIDED TO REPOSITION THE STEM TO COMPENSATE FOR THE BASEPLATE & RSQUO; S ANTEVERSION. THE FALL WAS NOT THE CAUSE OF THE BASEPLATE ANTEVERSION. THE PATIENT HAD AN ANTIBIOTIC SPACER DUE TO AN INFECTION AND A PREVIOUS COMPETITOR TSA. AS A RESULT, HIS GLENOID WAS SEVERELY ERODED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23510667 ↗
• InjuryJun 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN AFTER ACCIDENTALLY GETTING HIT IN THE SHOULDER AND STARTED FEELING UNSTABLE. THE SURGEON REVISED THE LINER AND GLENOSPHERE. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE LINER AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22284234 ↗
• InjuryJun 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR 2 MONTHS AFTER THE PRIMARY, THE PATIENT VISIT TO THE HOSPITAL DUE TO INFECTION. THE PATIENT VISITED THE HOSPITAL DUE TO INFECTION. THE IMPLANTS WERE REMOVED AND REPLACED WITH NEW ONES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22148010 ↗
• InjuryMay 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A LUXATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. AT ABOUT 5 MONTHS FROM PRIMARY THE SURGEON REVISED THE GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22043491 ↗
• InjuryApr 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 3 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FOR THE GLENOSPHERE. THE SURGEON REVISED THE LINER, METAPHYSIS AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 21926120 ↗
• InjuryApr 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21751408 ↗
• InjuryMar 26, 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. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT DISLOCATED AGAIN SO THE SURGEON CONVERTED THE REVERSE SHOULDER TO A HEMI. THE GLENOSPHERE DISLOCATED FROM THE LINER. THE LINER DID NOT DISSOCIATE FROM THE METAPHYSIS AND THE GLENOSPHERE DID NOT DISSOCIATE FROM THE BASEPLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 21697641 ↗
• InjuryFeb 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation; Perforation

  MAUDE report 21430786 ↗
• InjuryJul 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO A DISLOCATION OF THE LINER FOR THE GLENOSPHERE. AT ABOUT 1 YEAR POST PRIMARY. THE SURGEON REVISED THE LINER, GLENOPSHERE AND METAPHYSIS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 19708271 ↗
• InjuryJun 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT 2 MONTHS AND A HALF 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 LINER, GLENOSPHERE AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 19565505 ↗
• InjuryApr 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Pain

  MAUDE report 19094621 ↗
• InjuryFeb 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 MONTHS AND HALF AFTER 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 AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 18795923 ↗
• InjuryNov 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE GLENOSPHERE, LINER, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191336 ↗
• InjurySep 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Pain

  MAUDE report 17755250 ↗
• InjuryAug 29, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 3 MONTHS FROM THE PREVIOUS REVISION, THE PATIENT CAME IN REPORTING PAIN, DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE, AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE REVERSE METAPHYSIS AND REVISED THE 3MM LINER WITH A 6MM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 17641504 ↗
• InjuryAug 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT HAD A SHOULDER HEMI-ARTHROPLASTY SURGERY ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN AFTER FALLING AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT TO A REVERSE SHOULDER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023, 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 METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17489203 ↗
• InjuryJun 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION FOR SHOULDER LUXATION 1 MONTH AFTER PRIMARY. REVERSE SHOULDER GLENOSPHERE AND LINER WERE REVISED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 17069846 ↗
• InjuryMar 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED AT ABOUT 6 MONTHS AFTER PRIMARY DUE TO JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE METAPHYSIS AND THE LINER.

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

  MAUDE report 16467482 ↗
• InjuryNov 28, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A BONE IMPINGEMENT; THE CAUSE IS UNKNOWN. ABOUT 11 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER, METAPHYSIS AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY. EXPLANTS DID NOT SHOW ANY SIGNS OF ABNORMAL WEAR OR DAMAGE, AND IT IS NOT CONFIRMED THAT THERE WAS BONE IMPINGEMENT. THE DOCTOR THINKS THERE WAS SOME BONY ARTIFACT POSTERIOR BEHIND SOFT TISSUE CREATING A FULCRUM POINT. NO COMPONENTS WERE MOBILIZED OR MALPOSITIONED.

  Patient problems: Implant Pain

  MAUDE report 15869332 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14468726 ↗
• InjuryDec 13, 2021Osseointegration Problem; Patient Device Interaction Problem; Osseointegration Problem; Patient Device Interaction Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE GLENOSPHERE FROM THE LINER AND STEM LOOSENING 2 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE LINER, METAPHYSIS AND DIAPHYSIS.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 12983078 ↗