DELTA XTEND 2307-60-142Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295115991), received between Jul 10, 2023 and Jan 8, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2025Break; Illegible Information; Break; Illegible Information

  IT WAS REPORTED THAT PLASTIC PARTICLES COME LOOSE, AND THEY ARE SLUGGISH TO PUT ON THE ORIGINAL METAGLENPLATE DURING TESTING. ALL SURGERIES HAVE ABOUT A 5 MINUTE DELAY BECAUSE OF THIS. THE LOT NUMBER WAS TOO SMALL TO BE READ.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105215 ↗
• MalfunctionJan 8, 2025Break; Illegible Information; Break; Illegible Information

  IT WAS REPORTED THAT PLASTIC PARTICLES COME LOOSE, AND THEY ARE SLUGGISH TO PUT ON THE ORIGINAL METAGLENPLATE DURING TESTING. ALL SURGERIES HAVE ABOUT A 5 MINUTE DELAY BECAUSE OF THIS. THE LOT NUMBER WAS TOO SMALL TO BE READ.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105214 ↗
• MalfunctionDec 6, 2024Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT A PLASTIC REMNANT OF APPROXIMATELY 2 CM WAS LOOSENED FROM ONE OF THE TEST TRIAL GLEONOSPHERES, WHICH COULD BE PICKED UP FROM THE PATIENT'S SHOULDER JOINT. DIFFICULT TO SAY FROM WHICH OF THE TRIAL GLENOSPHERES THE REMNANT PLASTIC PART COMES FROM, SINCE THEY BOTH WERE SCRATCHED. USED IN 2 DIFFERENT SURGERIES THE SAME DAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20867129 ↗
• MalfunctionDec 6, 2024Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT A PLASTIC REMNANT OF APPROXIMATELY 2 CM WAS LOOSENED FROM ONE OF THE TEST TRIAL GLEONOSPHERES, WHICH COULD BE PICKED UP FROM THE PATIENT'S SHOULDER JOINT. DIFFICULT TO SAY FROM WHICH OF THE TRIAL GLENOSPHERES THE REMNANT PLASTIC PART COMES FROM, SINCE THEY BOTH WERE SCRATCHED. USED IN 2 DIFFERENT SURGERIES THE SAME DAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20867009 ↗
• MalfunctionNov 25, 2024Break; Break

  IT WAS REPORTED THAT THE PLASTIC MATERIAL GIVES DEBRIS IN THE JOINT; PLASTIC IS TOO SOFT. IT WAS WORN, SCRATCHED, WITH SMALL FRAGMENTS VISIBLE. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20770742 ↗
• MalfunctionNov 25, 2024Break; Entrapment of Device; Scratched Material; Break; Entrapment of Device; Scratched Material

  IT WAS REPORTED THAT DURING SURGERY, THE PLASTIC MATERIAL GIVES DEBRIS IN THE PATIENT'S SHOULDER JOINT. THE DEVICE WAS WORN, SCRATCHED, WITH SMALL FRAGMENTS VISIBLE. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20770715 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE GLENOSPHERE TRIAL WAS BROKEN AND CLEANED WITH SOFT AND BROKEN PLASTIC. THE HOSPITAL HAD DAMAGED TRIALS IN ALL THEIR SETS, AND THEY CAN NOT GUARANTEE THAT THE TRIAL BECAME STERILE AFTER CLEANING. THE HOSPITAL STAFF COMMENTED THAT IT FELT AS IF THE PLASTIC ON THE TRIALS WAS SOFTER THAN IT USED TO BE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20764716 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED, THAT ON AN UNKNOWN DATE. THE GLENOSPHERE TRIAL WAS BROKEN AND CLEANED WITH SOFT AND BROKEN PLASTIC. THE HOSPITAL HAD DAMAGED TRIALS IN ALL THEIR SETS. AND THEY CAN NOT GUARANTEE, THAT THE TRIAL BECAME STERILE AFTER CLEANING. THE HOSPITAL STAFF COMMENTED, THAT IT FELT AS IF THE PLASTIC ON THE TRIALS WAS SOFTER, THAN IT USED TO BE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20762771 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE GLENOSPHERE TRIAL WAS BROKEN AND CLEANED WITH SOFT AND BROKEN PLASTIC. THE HOSPITAL HAD DAMAGED TRIALS IN ALL THEIR SETS, AND THEY CAN NOT GUARANTEE THAT THE TRIAL BECAME STERILE AFTER CLEANING. THE HOSPITAL STAFF COMMENTED THAT IT FELT AS IF THE PLASTIC ON THE TRIALS WAS SOFTER THAN IT USED TO BE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761892 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE GLENOSPHERE TRIAL WAS BROKEN AND CLEANED WITH SOFT AND BROKEN PLASTIC. THE HOSPITAL HAD DAMAGED TRIALS IN ALL THEIR SETS, AND THEY CAN NOT GUARANTEE THAT THE TRIAL BECAME STERILE AFTER CLEANING. THE HOSPITAL STAFF COMMENTED THAT IT FELT AS IF THE PLASTIC ON THE TRIALS WAS SOFTER THAN IT USED TO BE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761890 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE GLENOSPHERE TRIAL WAS BROKEN AND CLEANED WITH SOFT AND BROKEN PLASTIC. THE HOSPITAL HAD DAMAGED TRIALS IN ALL THEIR SETS, AND THEY CAN NOT GUARANTEE THAT THE TRIAL BECAME STERILE AFTER CLEANING. THE HOSPITAL STAFF COMMENTED THAT IT FELT AS IF THE PLASTIC ON THE TRIALS WAS SOFTER THAN IT USED TO BE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761851 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED, THAT ON AN UNKNOWN DATE. THE GLENOSPHERE TRIAL WAS BROKEN AND CLEANED WITH SOFT AND BROKEN PLASTIC. THE HOSPITAL HAD DAMAGED TRIALS IN ALL THEIR SETS. AND THEY CAN NOT GUARANTEE, THAT THE TRIAL BECAME STERILE AFTER CLEANING. THE HOSPITAL STAFF COMMENTED, THAT IT FELT AS IF THE PLASTIC ON THE TRIALS WAS SOFTER, THAN IT USED TO BE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761850 ↗
• MalfunctionNov 22, 2024Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT INTRAOPERATIVELY IT WAS FOUND THAT THE PLASTIC MATERIAL OF THE PRODUCT IS SOFT AND DEBRIS LOOSENS FROM PRODUCT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761812 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THAT THE PLASTIC MATERIAL WAS TOO SOFT; THERE WAS DEBRIS IN JOINT. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 20761789 ↗
• MalfunctionNov 22, 2024Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  IT WAS REPORTED, THAT ON AN UNKNOWN DATE. THE GLENOSPHERE TRIAL WAS BROKEN AND CLEANED WITH SOFT AND BROKEN PLASTIC. THE HOSPITAL HAD DAMAGED TRIALS IN ALL THEIR SETS. AND THEY CAN NOT GUARANTEE, THAT THE TRIAL BECAME STERILE AFTER CLEANING. THE HOSPITAL STAFF COMMENTED, THAT IT FELT AS IF THE PLASTIC ON THE TRIALS WAS SOFTER, THAN IT USED TO BE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761198 ↗
• MalfunctionNov 22, 2024Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE GLENOSPHERE TRIAL WAS BROKEN AND CLEANED WITH SOFT AND BROKEN PLASTIC. THE HOSPITAL HAD DAMAGED TRIALS IN ALL THEIR SETS, AND THEY CAN NOT GUARANTEE THAT THE TRIAL BECAME STERILE AFTER CLEANING. THE HOSPITAL STAFF COMMENTED THAT IT FELT AS IF THE PLASTIC ON THE TRIALS WAS SOFTER THAN IT USED TO BE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761170 ↗
• MalfunctionNov 29, 2023Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THERE IS A SEVERE TEAR ON THE TEST GLENOSPHERE, BLACK PLASTIC PARTS VISIBLY COME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229174 ↗
• MalfunctionNov 2, 2023Break; Scratched Material; Break; Scratched Material

  TRIAL GLENOSPHERES ARE SCRATCHED ON THE BACKSIDE, SMALL PLASTIC FRAGMENTS WERE LOOSENING FROM THE TRIAL IMPLANT DURING INSERTION/ REMOVAL. PROCEDURE SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055686 ↗
• MalfunctionJul 10, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE 42MM STANDARD GLENOSPHERE TRIAL IS VERY NOTCHED, FRAGMENTS OF POLY COULD DISPLACE INTO THE JOINT SPACE. AFFECTS ACCURATE TRIAL REDUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295234 ↗
• MalfunctionJul 10, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT DEVICE HAS GENERAL WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286600 ↗