Shoulder System 04.01.0123Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 07630040706308), received between Apr 18, 2018 and Jul 9, 2026 — classified as 48 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (33 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 48 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PRIMARY LEFT SHOULDER SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE THAT WAS SUSTAINED WHILE THE PATIENT WAS SLEEPING. THE SURGEON REVISED THE GLENOSPHERE AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY (MDR 2022-00683). PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE GLENOSPHERE FROM 39XD 24.5 TO 42XD 24.5, THE METAPHYSIS +0MM/0° TO A SAME SIZE METAPHYSIS AND THE HUMERAL REVERSE HC LINER D 39/+3MM TO A HUM. REV. CONSTRAINED E-CROSS LINER D 42/+3. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 25763465 ↗
• InjuryMay 15, 2026Device Dislodged or Dislocated

  AT ABOUT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN FROM A PERIPROSTHETIC FRACTURE AT THE BASE OF THE HUMERAL STEM DUE TO A FALL. THE SURGEON CABLED THE FRACTURE AND REVISED THE METAPHYSIS FROM+0MM/0° TO +9MM/0° THE SHORT DIAPHYSIS TO A LONG DIAPHYSIS, AND THE LINER CHANGED FROM 39/+0MMTO D 39/+3MM. THE SURGERY WAS COMPLETED SUCCESSFULLY. ABOUT 2 MONTHS LATER, THE PATIENT PRESENTED WITH PAIN DUE TO DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. NO SIGNS OF TRAUMA WERE REPORTED. THE SURGEON REVISED THE HC LINER FROM D 39/+3MM TO A CONSTRAINED D 39/+0MM. SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 25185355 ↗
• InjuryMay 5, 2026Device Dislodged or Dislocated

  AT ABOUT 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A DISLOCATION OF THE LINER AND GLENOSPHERE AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE METAPHYSIS, THE LINER AND THE GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 25077232 ↗
• InjuryDec 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO DISLOCATION OF THE GLENOSPHERE AND THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER TO A SEMI-CONSTRAINED LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23876944 ↗
• InjuryDec 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD PRIMARY RIGHT SHOULDER SURGERY ON (B)(6) 2023. ON (B)(6)2025, THE PATIENT CAME IN REPORTING PAIN AND WHEN REVIEWING THE PATIENT’ SIMPLANTS TO PREPARE FOR THE REVISION, THE REPOBSERVED THAT A 27 GLENOSPHERE WAS IMPLANTED WITH A 24.5MM BASEPLATE DURING THE PRIMARY (WHICH IS A NON-COMPATIBLE COMBINATION AS REPORTED IN THE SURGICAL TECHNIQUE). IT IS UNKNOWN HOW OR WHY THIS OCCURRED. GLENOSPHERE, LINER AND METAPHYSIS REVISED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME DUE TO DISLOCATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER TO A CONSTRAINED LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23858634 ↗
• InjuryDec 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 3 WEEKS 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 REVISED THE LINER FROM A +3 TO A +6 AND REVISED THE METAPHYSIS FROM A +0MM/0° TO A +9MM/+20°R. THE GLENOSPHERE WAS NOT REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23858476 ↗
• InjuryNov 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER 1 MONTH FROM THE PRIMARY SURGERY, THE PATIENT REPORTED PAIN DUE TO A DISLOCATION, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, BASEPLATE, LINER, AND LOCKING SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 23583095 ↗
• InjuryOct 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ON (B)(6) 2025 PRIMARY SURGERY WAS PERFORMED. ON (B)(6) 2025 1ST REVISION SURGERY DUE TO IMPLANT DISLOCATION (SUSPECTED FALL) LINER REVISED. ON (B)(6) 2025 2ND REVISION SHOULDER SURGERY ON THE LEFT SIDE DUE TO INFECTION. EXPLANTATION OF ALL COMPONENTS AND IMPLEMENTATION OF A COMPETITION SPACER.

  Patient problems: Medical device site infection

  MAUDE report 23424406 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO INSTABILITY WITH THE CAUSE UNKNOWN. THE SURGEON REVISED THE METAPHYSIS, LINER (3 TO 6 MM) AND GLENOSPHERE (39 TO 42 LAT). THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 22961105 ↗
• InjuryAug 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED AT 10 MONTHS DUE TO JOINT LUXATION; THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE LINER, GLENOSPHERE AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. METAPHYSIS WAS REVISED TO GIVE THE PATIENT MORE VERSION SO IT WOULD BE DIFFICULT TO DISLOCATE IN THE FUTURE.

  Patient problems: Joint Dislocation

  MAUDE report 22911360 ↗
• InjuryJul 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PRIMARY SURGERY PERFORMED ON (B)(6) 2025. 1ST REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. 2ND REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. ON (B)(6) 2025, REVISION SURGERY WAS PERFORMED DUE TO JOINT LUXATION; LINER, GLENOSPHERE, AND METAPHYSIS REVISED. PATIENT HISTORY: PRIMARY SURGERY PERFORMED ON (B)(6) 2025. 1ST REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. (B)(4). 2ND REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. (B)(4). 3RD REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER, GLENOSPHERE, AND METAPHYSIS REVISED. (B)(4). 4TH REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE JOINT LUXATION; PATIENT CONVERTED TO HEMIARTHROPLASTY - GLENOSPHERE AND BASEPLATE REMOVED, LINER AND METAPHYSIS REPLACED WITH ANATOMICAL COMPONENTS (B)(4). 5TH REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO INTRA-PROSTHETIC DISLOCATION (METAL HUMERAL HEAD AND DOUBLE ECCENTER) - HUMERAL HEAD AND THE DOUBLE ECCENTRIC REVISED AND SURROUNDING BONE TRIMMED USING A RONGEUR. (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 22573896 ↗
• InjuryJul 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY AT ABOUT 1 MONTH POST-PRIMARY TO JOINT DISLOCATION. THE CAUSE OF THE LUXATION IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, LINER METAPHYSIS AND DIAPHYSIS WERE REVISED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22506236 ↗
• InjuryJun 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD PAIN DUE TO A DISLOCATION OF THE MEDACTA LINER FROM THE COMPETITOR GLENOSPHERE AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. AT ABOUT 2 MONTHS FROM PRIMARY THE SURGEON REVISED THE COMPETITOR GLENOSPHERE AND MEDACTA LINER AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22343742 ↗
• InjuryJun 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 MONTHS AND HALF AFTER THE 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 GLENOSPHERE, METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. METAPHYSIS REVISED BECAUSE THE SURGEON COULD NOT GET GOOD VISUALIZATION TO GET THE GLENOSPHERE IN ORIGINALLY, BUT WHEN THE SHOULDER DISLOCATED WITH THE 0 TRAY, HE WENT UP TO A +9.

  Patient problems: Implant Pain

  MAUDE report 22269610 ↗
• InjuryJun 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 4 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 22269573 ↗
• InjuryApr 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SURGERY ON THE (B)(6) 2021. THE SURGEON IMPLANTED REVERSE SHOULDER COMPONENTS AND BONE GRAFT WITH A CEMENTED STANDARD HUMERAL STEM. MYSHOULDER PLANNING WAS USED (B)(4). ON THE (B)(6) 2024, THE PATIENT UNDERGONE A FIRST REVISION DUE TO INFECTION (PROPIONI-BACTERIUM). EXPLANTATION OF ALL PRIMARY COMPONENTS. REIMPLANTATION OF NEW REVERSE SHOULDER COMPONENTS AND BONE GRAFT AND WITH A LONG HUMERAL STEM. ON THE (B)(6) 2024, THE PATIENT HAS BEEN REVISED FOR THE SECOND TIME BECAUSE OF JOINT LUXATION AND LOOSENING OF THE DIAPHYSIS. EXPLANTATION OF STEM, METAPHYSIS, LINER AND ALSO THE GLENOSPHERE WAS REMOVED IN ORDER TO TEST THE STABILITY OF THE BASEPLATE AND THE GRAFT. IMPLANTATION OF A LONG HUMERAL STEM (CEMENTED), METAPHYSIS, LINER +6MM (155 DEGREES) AND LATERALIZED GLENOSPHERE. ON THE (B)(6) 2024, THE PATIENT HAS BEEN REVISED FOR THE 3RD TIME DUE TO GRS BASEPLATE LOOSENING. EXPLANTATION OF ALL COMPONENTS EXCEPT THE LONG HUMERAL STEM. IMPLANTATION OF A GLENOID CUSTOM IMPLANT ON THE (B)(6) 2024 WITH MYSHOULDER PLANNING (B)(4). ON THE (B)(6) 2025, 4TH REVISION SURGERY PERFORMED DUE TO INFECTION. EXPLANTATION OF THE GLENOSPHERE, THE LINER AND THE METAPHYSIS. IMPLANT

  Patient problems: Joint Dislocation

  MAUDE report 21928711 ↗
• InjuryApr 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2025. ON (B)(6) 2025, 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. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION. DURING THE SURGERY, THE SURGEON NOTICED THAT THE LINER HAD DISSOCIATED FROM THE METAPHYSIS. THE SURGEON UPSIZED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON REPORTED THAT HE ENCOUNTERED NO ISSUE DURING THE FIRST REVISION WITH THE COULPLING OF THE LINER, WHICH WAS IMPLANTED WITH 145° INCLINATION. PATIENT WAS A MUSCULAR ONE. ADDITIONALLY, REVIEWING THE DETAILS OF THE PRIMARY SURGERY IT WAS NOTICED THAT A NOT CLEARED COMBINATION OF IMPLANTS WAS USED, NAMELY: GRS BASEPLATE - FULL WEDGE 10 WITH LAT. GLENOSPHERE.

  Patient problems: Joint Dislocation

  MAUDE report 21888365 ↗
• InjuryFeb 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 METAPHYSIS, GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 21458563 ↗
• InjuryFeb 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 WEEK FROM PRIMARY SURGERY, 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, LINER, METAPHYSIS, AND DIAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 21411258 ↗
• InjuryDec 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 20876419 ↗
• InjuryOct 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN 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: Implant Pain

  MAUDE report 20485245 ↗
• InjurySep 2, 2024Device 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 DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED SUCCESSFULLY THE LINER.

  Patient problems: Joint Dislocation

  MAUDE report 20117927 ↗
• InjuryJul 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH AFTER 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 ALL COMPONENTS WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 19826862 ↗
• InjuryJul 16, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, REVISION WAS PERFORMED DUE TO INFECTION. NO LOOSENING OF THE IMPLANTS AND EXCELLENT STABILITY OF THE BONE GRAFT IN PLACE. GLENOSPHERE AND LINER REVISED.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 19749509 ↗
• InjuryApr 15, 2024Device 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 DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, 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, LINER, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 19106325 ↗