GLOBAL 1137-84-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295007227), received between Feb 1, 2018 and Jun 20, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2023Naturally Worn; Naturally Worn

  REVISION OF LEFT SHOULDER ANATOMIC REPLACEMENT - REMOVAL OF ALL COMPONENTS SUSPECTED POLY WEAR/DEBRIS CAUSING SIGNIFICANT GLENOID WEAR - CUSTOM REVERSE ZIMMER COMPONENTS GOING BACK IN GLOBAL ADVANTAGE ORIGINAL IMPLANT (B)(6) 2008. (B)(6) HOSPITAL FOLLOWING UP WITH CS ON LOT NUMBERS OF IMPLANTS NO FURTHER INFO AVAILABLE. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> YES, FACILITY NAME OF ORIGINAL IMPLANT : (B)(6) WAR MEMORIAL , WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: AS ABOVE , DID PATIENT REQUIRE REVISION SURGERY? FALSE, PATIENT STATUS/ OUTCOME / CONSEQUENCES , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY : UNKNOWN, IP-01749407. DEVICE PROPERTY OF :NONE, DEVICE IN POSSESSION OF :NONE, IP-01749408. DEVICE PROPERTY OF :NONE, DEVICE IN POSSESSION OF :NONE, IP-01749409. DEVICE PROPERTY OF :NONE, DEVICE IN POSSESSION OF :NONE BY CHECKING THIS BOX I CERTIFY THAT

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17162903 ↗
• InjuryOct 19, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE GLENOID COMPONENT AT THE UNKNOWN INTERFACE.

  Patient problems: No Code Available; Pain

  MAUDE report 7985434 ↗
• InjuryFeb 1, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION ANATOMICAL TSR, DR. (B)(6), (B)(6) 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 7233815 ↗