GLOBAL AP 1130-10-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295005513), received between Mar 5, 2018 and Jan 28, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S ROTATOR CUFF BECAME UNSTABLE. SURGEON REVISED FROM AN ANATOMIC TO A REVERSE. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 21257062 ↗
• InjuryAug 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SURGEON ELECTED TO PERFORM A LEFT SHOULDER REVISION ARTHROPLASTY ON A PATIENT WHO HE PERFORMED A PRIMARY TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2010. SURGEON NOTED THAT THE PATIENT PERFORMED WELL POST OPERATIVELY AFTER HER PRIMARY SHOULDER ARTHROPLASTY UNTIL 2018 WHEN SHE EXPERIENCE SEVERAL DISLOCATIONS. SURGEON DID NOT SPECIFY THE EXACT NUMBER OF DISLOCATIONS OF THE LEFT SHOULDER. MOST RECENT DISLOCATION HAPPENED ON (B)(6) 2021 AND DOCTOR NOTED THEY HAD DIFFICULTY REDUCING THE PATIENT¿S SHOULDER THIS TIME BUT WERE SUCCESSFUL IN REDUCING IT. AFTERWARDS HE SAW THE PATIENT IN CLINIC AND TOOK FILMS WHICH SHOWED A SEPARATION OF THE HUMERAL IMPLANT AT THE 135 DEGREE TAPERED NECK SPACER AND THE HUMERAL STEM. THE TAPERED SPACER AND HUMERAL HEAD CONSTRUCT REMAINED INTACT. DOCTOR THEN ELECTED TO REVISE THE PATIENT¿S SHOULDER DUE TO THE SEPARATION ON WEDNESDAY, (B)(6) 2021 AT (B)(6) HOSPITAL. UPON EXPOSURE TO THE LEFT SHOULDER CUFF SURGEON FELT THE CUFF WAS COMPROMISED SEVERELY ENOUGH TO WARRANT A REVERSE SHOULDER REPLACEMENT THUS REQUIRING ALL PRIMARY COMPONENTS TO BE REVISED. DOCTOR WAS ABLE TO REMOVE THE TAPERED NECK SPACER AND HUMERAL HEAD CONSTRUCT WITH HIS HAND. HE THEN USED OSTEOTOMES,

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

  MAUDE report 12317069 ↗
• InjuryJun 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND TOTAL SHOULDER ARTHROPLASTY FAILURE. DOI: (B)(6) 2016; DOR: (B)(6) 2018; UNKNOWN AFFECTED SIDE.

  Patient problems: Pain

  MAUDE report 7613489 ↗
• InjuryMar 28, 2018Malposition of Device; Malposition of Device

  PRIMARY (B)(6) 2016, THIS IS FIRST REVISION FOR ONGOING PAIN, GLENOID LOOSENING AND STEM MALPOSITION.

  Patient problems: Not Applicable; Pain

  MAUDE report 7376994 ↗
• InjuryMar 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION TSR, DR (B)(6), (B)(6) HOSPITAL (B)(6) 2018. PRIMARY IMPLANT (B)(6) 2018. REVISION FOR: FRACTURED GREATER TUBEROSITY. PERI PROSTHETIC FRACTURE. PATIENT FELL AND FRACTURED GREATER TUBEROSITY. ON EVALUATION, SURGEON DECIDED A REVERSE TOTAL SHOULDER WOULD BE THE BEST PROCEDURE FOR FUNCTIONAL OUTCOME. FEMALE PATIENT INITIAL (B)(6), AGED (B)(6) YEARS. DOI: (B)(6) 2018; DOR: (B)(6) 2018; UNK SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 7365426 ↗
• MalfunctionMar 5, 2018Fitting Problem; Fitting Problem

  DER STATES THAT THE GLOBAL AP STEM WAS ASSEMBLED USING THE FIX 135 NECK ANGLE. THE SURGEON NOTICED AFTER IT WAS IMPLANTED THAT THE HEAD SAT PROUD . IT WAS REMOVED AND DISASSEMBLED. USING THE SAME STEM THEY CONVERTED IT TO A VARIABLE ANGLE AND THE WAS PREPARED AS PER TECHNIQUE BUT DID NOT MATCH THE TRIAL IMPLANT. THE SIZE 10 STEM WAS REPLACED WITH THE NEW STEM AND USED THE VARIABLE ANGLE AGAIN. THERE WAS A SURGICAL DELAY OF 20 MINUTES. DOE:(B)(6) 2018 RIGHT SHOULDER.

  Patient problems: Not Applicable

  MAUDE report 7312953 ↗