Shoulder System 04.01.0174Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630040706612), received between Mar 23, 2018 and May 13, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Device Dislodged or Dislocated

  IN (B)(6) 2026, ABOUT 3 MONTHS AFTER THE REVERSE SHOULDER IMPLANTATION, THE PATIENT PRESENTED AT THE CLINIC WITH COMPLAINTS FOLLOWING EXTENSIVE GARDENING WORK, AND A RADIOLOGICAL EXAMINATION REVEALED DISLOCATION OF THE GLENOSPHERE. THE SURGEON REVISED ONLY THE GLENOSPHERE. IT HAS BEEN REPORTED THAT THE GLENOSPHERE ORIENTER AND TORQUE LIMITER WAS USED DURING THE PRIMARY SURGERY. IN (B)(6) 2021, THE PATIENT RECEIVED AN ANATOMICAL SHOULDER PROSTHESIS FROM MEDACTA DUE TO OSTEOARTHRITIS. FOLLOWING A BICYCLE ACCIDENT IN (B)(6) 2026 AND THE RESULTING LIGAMENT INSTABILITY, THE ANATOMICAL PROSTHESIS WAS REPLACED WITH A REVERSE PROSTHESIS FROM MEDACTA. THE PREVIOUSLY IMPLANTED STEM REMAINED IN PLACE.

  Patient problems: Joint Dislocation

  MAUDE report 25160339 ↗
• MalfunctionApr 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ABOUT 2 YEARS AFTER THE PRIMARY SURGERY, XRAYS SHOWED THAT THE GLENOSPHERE ECCENTRICITY IS UPSIDE DOWN AND THAT THE GLENOSPHERE IS DISSOCIATED FROM THE BASEPLATE. REVISION SURGERY DATE IS NOT DEFINED YET. GLENOSPHERE GUIDE WAS NOT USED DURING THE PRIMARY SURGERY.

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

  MAUDE report 19151098 ↗
• InjuryMar 12, 2021Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  REVISION SURGERY PERFORMED 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION(SEPSIS) AND DISASSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE. METALLOSIS AND LINER DEFORMATION WAS VISIBLE DURING THE SURGERY. GLENOSPHERE, GLENOID POLYAXIAL LOCKING SCREW AND LINER WERE REMOVED. RE-LOCKING THE GLENOID POLYAXIAL LOCKING SCREW TO BE CERTAIN IT WAS LOCKED. PREVIOUSLY THIS PATIENT HAD COMPETITOR IMPLANTS IMPLANTED, BUT THE REASON OF ITS REMOVAL AND IMPLANTATION OF MEDACTA IMPLANTS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 11471403 ↗
• InjuryFeb 12, 2021Microbial Contamination of Device

  REVISION SURGERY 2 YEARS AND 6 MONTHS AFTER PRIMARY DUE TO INFECTION FROM THE HEMATOGENIC SOURCE. THE SURGEON REVISED ALL IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11320738 ↗
• InjuryOct 21, 2020Device Dislodged or Dislocated

  A MSS INVERSE OPERATION TOOK PLACE ON (B)(6) 2020. THE OPERATION WENT QUITE WELL SO FAR.ON (B)(6) 2020 THE PATIENT CAME TO THE CONSULTATION HOUR WITH THE DISSOCIATED GLENOSPHERE FROM THE BASEPLATE. ONE WEEK BEFORE, THE PATIENT HAD ALSO BEEN TO THE CONSULTATION AND EVERYTHING WAS FINE AND THE PATIENT WAS VERY SATISFIED. GLENOSPHERE REVISED 1 MONTH AFTER PRIMARY.

  Patient problems: Insufficient Information

  MAUDE report 10710584 ↗
• InjuryJun 21, 2019Device Dislodged or Dislocated

  SECOND REVISION SURGERY PERFORMED DUE TO GLENOSPHERE DISLOCATION 1 MONTH AFTER THE FIRST REVISION. THE DISLOCATION HAPPENED DURING AN EXERCISE AT THE CONVALESCENCE CENTER (PENDULUM). THE SURGEON REVISED THE GLENOSPHERE AND THE PE INLAY TO A +6 MM WITH THE INCLINATION OF 155° INSTEAD OF 145°.

  Patient problems: Joint Dislocation

  MAUDE report 8722204 ↗
• InjuryDec 28, 2018Loose or Intermittent Connection

  MEDACTA REVERSE SYSTEM WAS IMPLANTED ON (B)(6) 2018 REPLACING A COMPETITOR PROSTHESIS DUE TO SHOULDER LUXATION AND INFECTION. TWO MONTHS AFTER THE FIRST REVISION SURGERY, DURING THE FOLLOW-UP VISIT, THE SURGEON DISCOVERED THAT THE MEDACTA SHOULDER IS LUXATED. ALL COMPONENTS, EXCEPT FOR THE DIAPHYSIS, HAVE BEEN REMOVED PERFORMING A BONY INCREASED OFFSET REVERSED SHOULDER ARTHROPLASTY WITH BONE GRAFT.

  Patient problems: Unspecified Infection

  MAUDE report 8202408 ↗
• InjuryMar 23, 2018Device Slipped

  REVISION SURGERY PERFORMED DUE TO ANTERIOR LUXATION AFTER 5 MONTHS FROM THE PRIMARY. NOTCHING BETWEEN THE GLENOSPHERE AND THE METAPHYSIS PROXIMAL PART CAUSED METALLOSIS.

  Patient problems: Toxicity

  MAUDE report 7365115 ↗