GLOBAL AP 1130-10-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295005490), received between Nov 8, 2017 and Nov 25, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE IS LEFT. INFECTION WAS NOT CONFIRMED.

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

  MAUDE report 10900627 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENT IN THE DOCTOR'S OFFICE WITH A PAINFUL LEFT SHOULDER AND A DECREASE IN RANGE OF MOTION. SURGEON ORDERED A SERIES OF STUDIES AND FORMED THE OPINION THAT THE INDEX GLENOID COMPONENT WAS LOOSE. THE SURGEON REVISED THE SHOULDER. UPON EXPOSURE TO THE JOINT SPACE, DR. REMOVED THE 52X18 STANDARD HUMERAL HEAD FOR THE AP SHOULD SYSTEM, AND THE 135 TAPERED SPACER WITH THE STANDARD HEAD REMOVAL FORK IN THE GLOBAL AP TRAYS. THE SIZE 10 GLOBAL AP STANDARD STEM WAS KEPT IMPLANTED. SURGEON THEN EASILY REMOVED THE 52 ANCHOR PEG GLENOID WITH A PAIR OF KOCHERS. DUE TO BONE LOSS, SURGEON THEN IMPLANTED A COMPETITIVE GLENOID. NO INSTRUMENTATION BROKE DURING SURGERY AND THERE WERE NO DELAYS.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10240910 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATSR: (B)(6), (B)(6) 2019. THE PATIENT HAD A RIGHT GLOBAL AP AND ANCHOR PEG GLENOID ATSR ON (B)(6) 2019. PT HAD NORMAL POST-OP RECOVERY AND EARLY REHAB. POST-OP TRAUMA WITH SIGNIFICANT FALL 1-MONTH POST-OP. PAINFUL SINCE. NO FRACTURES OR OBVIOUS DISRUPTION OF COMPONENTS. GOOD RANGE OF MOVEMENT, BUT THE PAIN PERSISTED. INVESTIGATED FOR INFECTION, SOME P ACNE? SCANNED AND HOT SPOTS BOTH GLENOID AND PROXIMAL HUMERUS. THE ARTHROSCOPIC INVESTIGATION,? LOOSE. REVISED TO DELTA XTEND RTSR TODAY. ANCHOR PEG GLENOID COMPONENT HAD NO EVIDENCE OF OSTEOINTEGRATION AND WAS RELATIVELY EASY TO REMOVE. GLOBAL AP COMPONENTS APPEARED WELL FIXED. NORMAL POST-OP RECOVERY EXPECTED. NO AE REPORTED, NO DELAY IN THE SURGERY. MALE PATIENT, INITIALS: (B)(6)., ACTIVE AND HEALTHY PT, RELEVANT PATIENT PRE-EXISTING CONDITIONS: PREVIOUS GLOBAL AP AND ANCHOR PEG GLENOID ATSR LEFT SIDE, FUNCTIONING WELL. X-RAY AND CT ARE AVAILABLE.

  Patient problems: Fall; Pain; Unspecified Infection

  MAUDE report 9459956 ↗
• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND SEVERE ROTATOR CUFF TEAR THUS ALL HER COMPONENTS WERE REMOVED AND A NEW CONSTRUCT WAS PLACED. THE PATIENT UNDERWENT A GLOBAL AP CTA CONSTRUCT SOMETIME IN THE PAST. DOI: UNKNOWN. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8768037 ↗
• InjuryFeb 1, 2018Loss of Osseointegration; Loss of Osseointegration

  REVISION ANATOMICAL TSR DR (B)(6), (B)(6) PRIVATE HOSPITAL (B)(6) 2018. PRIMARY PERFORMED BY A DIFFERENT SURGEON, (B)(6) 2008. PATIENT COMPLAINED OF 12 MONTHS OF MILD SHOULDER PAIN. SHOULDER ARTHROSCOPY PERFORMED 2 WEEKS AGO & GLENOID NOTED TO BE LOOSE. PATHOLOGY NOTES INCREASED CRP & STAPH. INFECTION. SURGEON REMOVED GLENOID, HEAD AND THEN STEM WITH TAPER ATTACHED, AS STEM WAS LOOSE. SYNOVIAL TISSUE & GLENOID COMPONENT SENT OFF BY SURGEON TO BE CULTURED. IMPLANTING NEW STEM, TAPER AND HEAD.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7233866 ↗
• InjuryNov 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 7009421 ↗