ARROW® 265152 - CoCr GLENOSPHERE, Ø42Recalls & reported problems
Fournitures Hospitalieres Industrie · Class 2 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03661489651526), received between Mar 8, 2018 and Dec 3, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation3
- Device Contaminated During Manufacture or Shipping1
- Device Packaging Compromised1
- Fracture1
- Incomplete or Missing Packaging1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Insufficient Information4
- Not Applicable1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2024Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth
LOOSENING OF THE SPHERE AFTER 18 MONTHS OF IMPLANTATION. THE SURGEON HASN'T PROCEEDED TO THE REVISION. A REVISION IS SCHEDULED FOR (B)(6). FOR THE MOMENT, WE HAVE NO INFORMATION ON DEVICE REFERENCES OR BATCHES.
Patient problems: Insufficient Information
MAUDE report 20835339 ↗MalfunctionAug 19, 2021Material Separation; Material Separation
THE PATIENT ADMITTED TO MOVING HEAVY WASHER/DRYER UNITS EARLIER IN (B)(6) AND UPON EXAMINATION,THE DOCTOR DETERMINED GLENOSPHERE HAD DISLODGED FROM METAL BACK BASEPLATE. APPEARS CAP SCREW HAS SHEARED OFF AND FLOATING IN SHOULDER. REVISION TO TAKE PLACE (B)(6) 2021.
Patient problems: Insufficient Information
MAUDE report 12342867 ↗MalfunctionAug 19, 2021Material Separation; Material Separation
THE PATIENT ADMITTED TO A TRAUMATIC EVENT (FALL) EARLIER IN (B)(6) AND UPON EXAMINATION, DR. (B)(6) DETERMINED GLENOSPHERE HAD DISLODGED FROM METAL BACK BASEPLATE. REVISION TO TAKE PLACE (B)(6) 2021.
Patient problems: Insufficient Information
MAUDE report 12342859 ↗MalfunctionAug 19, 2021Material Separation; Material Separation
THE PATIENT RECENTLY SEEN BY DOCTOR. ORIGINAL SURGERY WAS DONE (B)(6) 2018. THE PATIENT'S WIFE MADE MENTION THAT HUSBAND HAD BEEN RECENTLY DOING EXTENUOUS YARD WORK. GLENOSPHERE HAS OBVIOUSLY BECOME DISLODGED FROM BASEPLATE. REVISION TO TAKE PLACE (B)(6) 2021.
Patient problems: Insufficient Information
MAUDE report 12342853 ↗MalfunctionMar 8, 2018Incomplete or Missing Packaging; Device Packaging Compromised; Device Contaminated During Manufacture or Shipping; Incomplete or Missing Packaging; Device Packaging Compromised; Device Contaminated During Manufacture or Shipping
DES RÉSIDUS BLANCS ONT ÉTÉ OBSERVÉS SUR PLUSIEURS IMPLANTS. LE CHIRURGIEN A DÛ EN NETTOYER UN AVANT DE L'IMPLANTER. WHITE RESIDUES WERE PRESENT ON SEVERAL IMPLANTS. THE SURGEON HAD TO WASH ONE IN ORDER TO IMPLANT IT.
Patient problems: Not Applicable
MAUDE report 7322852 ↗
Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.