Shoulder System 04.01.0126Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07630040706339), received between May 16, 2019 and May 5, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

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

  THE PATIENT HAD PRIMARY SURGERY ON (B)(6) 2019. 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 GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO CHRONIC INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WERE NO REPORTS OF TRAUMA. THE SURGEON REMOVED ALL MEDACTA IMPLANTS AND CONVERTED TO A COMPETITOR PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 25077233 ↗
• InjuryJan 29, 2026Device Dislodged or Dislocated

  REVISION SURGERY ABOUT 11 MONTHS AFTER THE PRIMARY SURGERY DUE TO JOINT LUXATION. LINER REVISED WITH A CONSTRAINED LINER.

  Patient problems: Joint Dislocation

  MAUDE report 24208600 ↗
• InjurySep 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 MONTHS 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 UPSIZED THE LINER TO PREVENT FUTURE DISLOCATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23013449 ↗
• InjuryJul 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PRIMARY SURGERY PERFORMED ON (B)(6) 2025. FIRST REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. ON (B)(6) 2025, A SECOND REVISION SURGERY WAS PERFORMED DUE TO JOINT LUXATION; THE LINER AND GLENOSPHERE WERE REVISED. THE GLENOSPHERE WAS CHANGED FROM 42MM STD TO 39MM/+3MM LAT AND THE LINER FROM 42MM/+3MM TO 39MM/+3MM. 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 22573884 ↗
• InjuryJul 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT 5 YEARS 6 MONTHS 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 UPSIZED THE POLY AND IMPLANTED A LATERALIZED GLENOSPHERE TO PREVENT RECURRENT DISLOCATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22436993 ↗
• InjuryMar 3, 2025Device 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 AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 21503414 ↗
• InjurySep 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2023. ON THE (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A JOINT LUXATION. THE SURGEON REVISED THE GLENOSPHERE AND LINER. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A JOINT LUXATION. THE SURGEON REVISED FOR THE SECOND TIME THE GLENOSPHERE AND LINER. 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 LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20154555 ↗
• MalfunctionApr 10, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE LINE MARKING FOR 145/155 DEGREE ORIENTATION WAS PLACED ON THE WRONG END ON THE PE LINER SIZE 42MM HEIGHT + 3MM. WHEN INSERTING THE PE LINER INTO THE STANDARD REVERSE METAPHYSIS THE SURGEON NOTICED THE LINE MARKING WAS ON THE WRONG SIDE. THE PE LINER WAS THEN PLACED AT THE CORRECT ANGLE THAT THE SURGEON WANTED (145 DEGREES) WITH THE THICKER LIP OF THE PE LINER PLACED LATERALLY, DESPITE THE LINE BEING ON THE THINNER PART OF THE POLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19078445 ↗
• InjuryApr 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO SHOULDER LUXATION.

  Patient problems: Joint Dislocation

  MAUDE report 19041405 ↗
• InjuryMay 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6)2023. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023, THE PATIENT CAME REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE LINER AND GLENOSPHERE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6)2023, THE PATIENT CAME 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. PRESENTLY, ON (B)(6)2023, THE PATIENT CAME IN DUE TO SIGNS OF A DISLOCATION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A SALVAGE HEMIARTHROPLASTY WITH AN ANATOMICAL METAPHYSIS, DOUBLE ECCENTER, AND HUMERAL HEAD AND EXPLANTED THE BASEPLATE, SCREWS, GLENOSPHERE, REVERSE METAPHYSIS, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16992286 ↗
• InjuryApr 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER WITH A THICKER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER AND GLENOSPHERE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16741416 ↗
• InjuryJun 13, 2022Device Dislodged or Dislocated

  THE PATIENT HAD PRIMARY SHOULDER SURGERY ON 7 MARCH 2022. ON 6 APRIL 2022, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE METAPHYSIS AND LINER. PRESENTLY, ON 16 MAY 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO DISLOCATION AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS EXCEPT FOR THE STEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON CONVERTED THE PATIENT TO A HEMIARTHROPLASTY.

  Patient problems: Joint Dislocation

  MAUDE report 14675294 ↗
• InjuryApr 20, 2022Device Dislodged or Dislocated

  REVISION OF METAPHYSIS, GLENOSPHERE, AND LINER ALMOST 1 MONTH AFTER PRIMARY FOLLOWING SHOULDER LUXATION. MAYBE THERE WERE BONE PIECES AROUND THE GLENOSPHERE THAT CONTRIBUTED TO THIS EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 14159950 ↗
• InjuryMay 16, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 20 DAY AFTER PRIMARY THE SURGEON REVISED THE REVERSE METAPHYSIS, THE REVERSE LINER, THE GLENOSPHERE, THE GLENOID BASEPLATE AND THE GLENOID LOCKING SCREWS FOR A DISLOCATION CASE (HUMERUS FROM GLENOID). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 8615715 ↗