Shoulder System 04.01.0173Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 07630040706605), received between Sep 21, 2018 and Sep 9, 2026 — classified as 50 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (28 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 52 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Device Appears to Trigger Rejection

  After a review of the custom reverse shoulder glenoid following a primary surgery, the surgeon observed some lucency around the screws in the glenoid along with a positive culture test for Cutibacterium acnes. The surgeon treated the patient with intravenous antibiotics along with oral antibiotics. The patient`s labs were stable and physical exam were good in a follow-up on (b)(6) 2025.

  Patient problems: Medical device site infection

  MAUDE report 50692292 ↗
• InjuryJun 9, 2026Device Dislodged or Dislocated

  REVISION SURGERY AT ABOUT 3 WEEKS FROM SURGERY FOR SHOULDER LUXATION. THE SURGEON REVISED SUCCESSFULLY GLENOSPHERE, LINER ANDMETAPHYSIS.

  Patient problems: Joint Dislocation

  MAUDE report 25442525 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  ACROMION FRACTURE POSTOPERATIVELY, ABOUT 11 MONTHS POST PRIMARY. REASON UNKNOWN. THE SURGEON IS TREATED CONSERVATIVELY WITH PHYSIOTHERAPY AND SPLINT/IMMOBILIZATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 25297690 ↗
• InjuryApr 20, 2026Device Dislodged or Dislocated

  JOINT LUXATION OCCURRED ABOUT 1 WEEK AFTER THE PRIMARY SURGERY. ANOTHER LUXATION OCCURRED TWO WEEKS AFTER THE PRIMARY SURGERY. ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED. GLENOSPHERE SIZE INCREASED (DIAMETER 42), LINER +6MM AND METAPHYSIS+9MM/+20° R IMPLANTED. PATIENT HAS A BONE GRAFT.

  Patient problems: Joint Dislocation

  MAUDE report 24924657 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 3 MONTHS AFTER THE PREVIOUS SURGERY (IT WAS DUE TO INFECTION) DUE TO SHOULDER INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 24882480 ↗
• InjuryDec 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION ABOUT 1 MONTH AFTER THE PRIMARY SURGERY. GLENOSPHERE, LINER, AND METAPHYSIS REVISED.

  Patient problems: Medical device site infection

  MAUDE report 23837285 ↗
• InjuryNov 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PRIMARY SURGERY PERFORMED ON THE (B)(6) 2025. IMPLANTATION OF REVERSE SHOULDER IMPLANTS. REVISION SURGERY PERFORMED ON THE (B)(6) 2025 DUE TO SUSPECTED INFECTION. EXPLANTATION OF THE HUMERAL PE LINER, GLENOSPHERE AND METAPHYSIS. REIMPLANTATION OF NEW IMPLANTS WITH SAME SIZES.

  Patient problems: Medical device site infection

  MAUDE report 23480204 ↗
• InjuryJul 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PRIMARY SURGERY: PERFORMED TO TREAT A FRACTURE WITH A LONG SHAFT. PRIMARY DATE AND DETAILS UNKNOWN. 1ST REVISION (DUE TO INFECTION): THE SURGEON REMOVED ONLY THE GLENOID, LEFT THE SHAFT IN PLACE, AND IMPLANTED A SPACER HEAD WITH CEMENT. SURGERY DATE AND DETAILS UNKNOWN. 2ND REVISION (CUSTOM GLENOID IMPLANTATION): PERFORMED ON (B)(6) 2025 TO IMPLANT CUSTOM GLENOID AFTER THE INFECTION WAS TREATED. 3RD REVISION (DUE TO SHOULDER LUXATION): PERFORMED FOLLOWING MULTIPLE LUXATIONS AFTER THE CUSTOM IMPLANT. IT WAS REPORTED THAT THE REVISION IS DUE TO POOR SOFT TISSUE TENSIONING. SURGERY DATE AND DETAILS UNKNOWN. 4TH REVISION (PLANNED FOR (B)(6) 2025): AFTER FURTHER DISLOCATIONS, DR. (B)(6) CONSULTED PROF. (B)(6) WHO WILL PERFORM A REVISION SURGERY IN (B)(6).

  Patient problems: Joint Dislocation

  MAUDE report 22574585 ↗
• InjuryJun 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AT ABOUT 2 YEARS AND 5 MONTHS FROM THE PRIMARY. NO FINAL IMPLANTS WERE IMPLANTED, ONLY A SPACER BECAUSE OF THE INFECTION. LATER ON, THE SURGEON WILL PUT IN NEW IMPLANTS.

  Patient problems: Medical device site infection

  MAUDE report 22326363 ↗
• InjuryMay 8, 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 1 MONTH AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF RECURRENT JOINT LUXATION THAT OCCURRED DURING HOSPITALIZATION AND AT HOME AFTER THE SURGERY. LINER, GLENOSPHERE AND METAPHYSIS REVISED SUCCESSFULLY.

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

  MAUDE report 21984140 ↗
• InjuryApr 4, 2025Device Appears to Trigger Rejection; Device Dislodged or Dislocated; Device Appears to Trigger Rejection; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO INFECTION AND INSTABILITY, PATIENT REPORTED ALSO DISLOCATION. GLENOSPHERE, LINER AND THE METAPHYSIS REVISED. PRIMARY SURGERY PERFORMED BY DR (B)(6) ON THE (B)(6)2021. IMPLANTATION OF REVERSE SHOULDER COMPONENTS + BONE GRAFT AND WITH A CEMENTED STANDARD HUMERAL STEM. MYSHOULDER PLANNING ONLY (M_MIC_RTS_YB_04031948). 1ST REVISION SURGERY PERFORMED ON THE (B)(6) 2024. EXPLANTATION OF ALL PRIMARY COMPONENTS. REIMPLANTATION OF NEW REVERSE SHOULDER COMPONENTS + BONE GRAFT AND WITH A LONG HUMERAL STEM. 2ND REVISION SURGERY PERFORMED ON THE (B)(6) 2024. EXPLANTATION OF THE LONG HUMERAL STEM WITH THE METAPHYSIS AND THE LINER + EXPLANTATION OF 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) + IMPLANTATION OF A NEW GLENOSPHERE (LATERALIZED). 3RD REVISION SURGERY PERFORMED ON THE (B)(6) 2024. EXPLANTATION OF ALL COMPONENTS EXCEPT THE LONG HUMERAL STEM. IMPLANTATION OF A GLENOID CUSTOM IMPLANT ON THE (B)(6) 2024 WITH MY SHOULDER PLANNING (M_MOU_RTS_YB_04031948). 4TH REVISION SURGERY PERFORMED ON THE (B)(6) 2025. EXPLANTATION OF THE GLENOSPHERE,

  Patient problems: Joint Dislocation; Joint Laxity; Medical device site infection

  MAUDE report 21771301 ↗
• MalfunctionMar 25, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NOT FULLY SEATED GLENOSPHERE SCREW WAS NOTED FROM POST-OPERATIVE XRAYS PERFORMED ABOUT 3 MONTHS POST PRIMARY SURGERY. DURING THE SURGERY, THE GLENOSPHERE WAS INSERTED USING THE RETENTIVE GLENOSPHERE IMPACTOR OVER THE FLEXIBLE GLENOSPHERE GUIDE. THE TORQUE LIMITING SCREW DRIVER T15 3NM WAS USED TO SCREW THE GLENOSPHERE SCREW INTO THE BASEPLATE. AT THE MOMENT, THERE IS NO INTENTION TO PERFORM AN ADDITIONAL SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 21687568 ↗
• MalfunctionMar 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NOT FULLY SEATED GLENOSPHERE SCREW WAS NOTED FROM POST-OPERATIVE XRAYS PERFORMED ABOUT 2 MONTHS POST PRIMARY SURGERY. DURING THE SURGERY, THE GLENOSPHERE WAS INSERTED USING THE RETENTIVE GLENOSPHERE IMPACTOR OVER THE FLEXIBLE GLENOSPHERE GUIDE. THE TORQUE LIMITING SCREW DRIVER T15 3NM WAS USED TO SCREW THE GLENOSPHERE SCREW INTO THE BASEPLATE. AT THE MOMENT, THERE IS NO INTENTION TO PERFORM AN ADDITIONAL SURGERY.

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

  MAUDE report 21662620 ↗
• InjuryFeb 25, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACROMIAL STRESS FRACTURE OCCURRED APPROXIMATELY 2 MONTHS POST SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 21456686 ↗
• InjuryFeb 25, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACROMIAL STRESS FRACTURE OCCURRED APPROXIMATELY 2 MONTHS POST SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 21456685 ↗
• InjuryFeb 25, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACROMIAL STRESS FRACTURE OCCURRED APPROXIMATELY 3 MONTHS POST SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 21456684 ↗
• InjuryJan 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO JOINT LUXATION, AT ABOUT 2 MONTHS AFTER THE PRIMARY. THE SURGEON CHANGED THE HUMERAL LINER AND THE GLENOSPHERE. PRIMARY SURGERY PERFORMED IN (B)(6) 2024 ((B)(6) 2024)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21262087 ↗
• InjuryJan 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 21092769 ↗
• InjuryNov 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO JOINT LUXATION, AT ABOUT 7 MONTHS AFTER PRIMARY. THE SURGERY HAS BEEN COMPLETED SUCCESSFULLY REVISING THE LINER AND THE GLENOSPHERE.

  Patient problems: Joint Dislocation

  MAUDE report 18198434 ↗
• InjuryApr 26, 2023Migration; Migration

  THE PATIENT HAD A PRIMARY SURGERY ON THE (B)(6) 2022. AT ABOUT 10 MONTHS AFTER THE PRIMARY, FROM THE X-RAYS HAS BEEN NOTICED THE UNSCREWING OF THE SCREW FROM THE GLENOSPHERE. THE SURGEON DO NOT PLAN TO REVISE THE IMPLANT AT THIS TIME AND CONTINUES WITH THE FOLLOW-UP OBSERVATION.

  Patient problems: Implant Pain

  MAUDE report 16813415 ↗
• InjuryOct 31, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH AND 3 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME REPORTING PAIN DUE TO ANTERIOR DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 15698469 ↗
• InjuryAug 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY AT ABOUT 4 YEARS AND 3 MONTHS POST PRIMARY FOR GLENOSPHERE INTRAPROSTHETIC DISLOCATION FROM THE BASEPLATE. DURING THE PRIMARY SURGERY ONE OF THE GLENOSPHERE POLYAXIAL SCREW PRONG DEFORMED.

  Patient problems: Joint Dislocation

  MAUDE report 15247457 ↗
• InjuryFeb 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE SURGEON REVISED THE GLENOSPHERE AND THE LINER 2 YEARS AND 3 MONTHS AFTER PRIMARY FOLLOWING GLENOSPHERE SCREW LOOSENING. THE GLENOSPHERE WAS COMPLETELY MOBILE, BUT NOT DISPLACED. THE SCREW WAS COMPLETELY LOOSE ALSO, BUT STILL IN THE GLENOSPHERE.

  Patient problems: Insufficient Information

  MAUDE report 13557274 ↗
• InjuryFeb 15, 2022Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  ABOUT 6 MONTHS AFTER THE PRIMARY SURGERY, THE SCREW OF THE GLENOSPHERE BECAME LOOSE AND THE GLENOSPHERE WAS NOT FIXED ANYMORE. REVISION SURGERY PERFORMED ON (B)(6) 2022.

  Patient problems: Failure of Implant

  MAUDE report 13532819 ↗
• InjuryFeb 9, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY WILL BE PERFORMED ABOUT 1 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY DUE TO GLENOSPHERE SCREW LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 13498302 ↗