Shoulder System 04.01.0159Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630040706469), received between Jul 31, 2020 and Nov 18, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Fracture; Fracture

  INTRAOPERATIVELY, THE SURGEON INITIALLY JUDGED THAT THE HEAD HAD MERELY BEEN STRIPPED. HOWEVER, A POSTOPERATIVE X-RAY REVEALED THAT THE BROKEN SCREW HEAD HAD MIGRATED AND ENTERED THE HUMERUS. ON THE SAME DAY, ADDITIONAL SURGICAL INTERVENTION WAS PERFORMED TORE MOVE THE SCREW FRAGMENT THROUGH AN INCISION. THE CAUSE IS UNKNOWN, BUT IT IS POSSIBLE THAT THE SCREW HEAD BROKE DURING THE FINAL TIGHTENING PHASE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE TOTAL SURGERY TIME WAS 2 HOURS, AND THE DELAY TIME WAS 1 HOUR. THE SCREW INVOLVED WAS LOCATED IN THE SUPERIOR PART OF THE BASEPLATE. A TOTAL OF FOUR POLYAXIAL SCREWS, INCLUDING THE BROKEN ONE, WERE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583100 ↗
• InjuryDec 27, 2024Fracture; Device Appears to Trigger Rejection; Fracture; Device Appears to Trigger Rejection

  REVISION SURGERY PERFORMED 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO SUSPECTED SEPTIC LOOSENING AND METALLOSIS ON THE HUMERAL AND GLENOID PART. BONE GRAFT USED IN PRIMARY SURGERY. ONE POLYAXIAL SCREW WAS FOUND BROKEN. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PUT IN.

  Patient problems: Medical device site infection; Metal Related Pathology

  MAUDE report 21026680 ↗
• MalfunctionAug 11, 2022Fracture; Fracture

  2 GLENOID POLYAXIAL LOCKING SCREW PRONG HEADS BROKE WHILE THE SURGEON WAS TRYING TO INSERT THEM IN THE GLENOID BASEPLATE (1X 22MM, 1X 26MM). FINALLY A GLENOID BONE FRACTURE OCCURRED AND THE SURGEON DECIDED TO SWITCH TO AN ANATOMICAL SYSTEM. THE BONE WAS VERY HARD.

  Patient problems: Bone Fracture(s)

  MAUDE report 15208238 ↗
• InjuryJun 24, 2021Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING PAIN DUE TO THE SCREW PLACED IN THE GLENOID IN THE PRIMARY HITTING A NERVE. 8 MONTHS AFTER THE PRIMARY, THE SURGEON REVISED THE SCREW WITH A SHORTER SCREW. THE SURGEON ALSO REVISED THE GLENOSPHERE, HUMERAL REVERSE METAPHYSIS, AND HUMERAL REVERSE LINER SINCE THE JOINT LOOSENED UP INTRAOPERATIVELY UNEXPECTEDLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Nerve Damage

  MAUDE report 12057829 ↗
• InjuryJul 31, 2020Appropriate Device Problem Term/Code Not Available

  DURING THE FIRST SURGERY (2018) THERE WAS AN INTRA-OP CAUDAL GLENOID FRACTURE DURING THE IMPLANTATION OF AN INVERSE SHOULDER IMPLANT. THE SURGEON REPORTED TO AGENT THAT HE HAS IN SUCH CASES 2 OPTIONS: 1) GO FOR A HEMI PROTHESIS OR 2) GO FOR AN INVERSE PROTHESIS BUT IMPLANT IT TOO CRANIAL AND THEN LATER REVISE THE GLENOID SIDE FOR A ANATOMIC POSITION AFTER FRACTURE HEALING AND IN CASE OF PROBLEM. THE SURGEON HAS CHOSEN OPTION 2 TO GO ON. THIS REVISION OF TODAY WAS THE REVISION OF THE OPTION 2 - A "PLANNED REVISION". THE SURGEON TOLD ME THAT THE REVISION IS NOT IMPLANT RELATED. DIAPHYSIS WAS NOT REMOVED. ALL OTHER COMPONENTS WERE REMOVED AND SENT TO SONIFICATION (WHY NOT AVAILABLE).

  Patient problems: Bone Fracture(s)

  MAUDE report 10349979 ↗