DELTA XTEND 2307-60-138Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295115984), received between Feb 22, 2019 and Apr 2, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Break

  IT WAS REPORTED THAT DURING REMOVAL OF OF TRIAL GLENOSPHERE 38 A CLEARLY VISIBLE PLASTIC REMNANT WAS OBSERVED AND REMOVED FROM THE PATIENT. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766235 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT DURING A REVERSE SHOULDER PROCEDURE THE INTERNAL SCREW IN THE METAGELENE TRIAL CAME OUT. THE SURGEON AND SCRUB NURSE THOUGHT IT WAS BECAUSE THE T-HANDLE'S THREAD WAS BARE AND THEREFORE WASN¿T SCREWING BUT PUSHING ON THE TRIAL SCREW. NO DETERMINANT TO THE PATIENT. MINOR DELAY TO SURGERY DUE TO THE BACK UP KIT BEING OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740307 ↗
• 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 21105209 ↗
• MalfunctionJan 8, 2025Break; Device-Device Incompatibility; Illegible Information; Break; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT THE PLASTIC PARTICLES COME LOOSE AND THEY ARE SLUGGISH TO PUT ON THE ORIGINAL METAGLENPLATE DURING TESTING CAN NOT READ LOT NO. IT IS TOO SMALL. ALL SURGERIES HAVE ABOUT 5 MIN DELAY BECAUSE OF THIS. THE EVENT DAY UNKNOWN, EVENT MONTH DECEMBER 2024.

  Patient problems: Insufficient Information

  MAUDE report 21101801 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, A GLENOSPHERE TRIAL BROKE INTO TWO PIECES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20822211 ↗
• 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 20765505 ↗
• MalfunctionNov 22, 2024Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT : ¿ WERE THESE FAILURES FOUND PRE-OP/INTRA-OP/POST OP? THE DAMAGE TO THE INSTRUMENT IS DONE DURING SURGERY BUT SEEN AFTER THE INSTRUMENT IS USED. INSPECTION DONE POST OP. ¿ WHEN YOU STATE DEBRIS IN JOINT, DO YOU MEAN THE PATIENTS JOINT? YES, PATIENTS SHOULDER JOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20765391 ↗
• 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 20764509 ↗
• 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 20762662 ↗
• MalfunctionNov 22, 2024Break; Entrapment of Device; Scratched Material; Break; Entrapment of Device; Scratched Material

  IT WAS REPORTED THAT THE PLASTIC MATERIAL IS SCRATCHED. PLASTIC DEBRIS ARE SEEN IN JOINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20761905 ↗
• 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 20761796 ↗
• 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 20761793 ↗
• 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 20761733 ↗
• 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 20761177 ↗
• MalfunctionOct 15, 2024Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE SURGEON WAS DOING A DELTA XTEND REVERSE SHOULDER REPLACEMENT TODAY AND REPORTED THAT THE METAGLENE HOLDER AND METAGLENE HOLDER INTERNAL ROD WERE NOT HOLDING THE METAGLENE GUIDE PLATE EFFECTIVELY AS IT WAS LOOSE. ALSO THE SIZE 38 GLENOSPHERE TRIAL WAS DAMAGED BY INSTRUMENTS AND MISUSE. THE PLASTIC WAS SCRATCHED AND SHREDDED ON THE INNER ASPECT OF THE GLENOSPHERE. THERE WAS MINIMAL DELAY TO THE SURGERY WHILST REATTACHING METAGLENE PLATE. THERE WAS NO KNOW PATIENT ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451589 ↗
• MalfunctionJul 13, 2023Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE 38MM 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 17320750 ↗
• MalfunctionJul 10, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE 38MM 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 17295151 ↗
• MalfunctionJul 10, 2023Break; Scratched Material; Break; Scratched Material

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE REAMER JUST SPINS AS OPPOSED TO FORWARD AND BACKWARD REAMING ACTION..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287587 ↗
• MalfunctionMar 29, 2023Break; Break

  IT WAS REPORTED THAT THE STANDARD GLENOSPHERE 38MM HEAD TRIAL BROKE. THE MIDDLE METAL HEX CONNECTION POPPED OUT OF TRIAL. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16636274 ↗
• MalfunctionOct 6, 2022Break; Break

  IT WAS REPORTED THAT THE GLENOSPHERE HAS A LARGE CHIP .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15551225 ↗
• MalfunctionFeb 22, 2019Break; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Break; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CENTRAL METAL LOCKING MECHANISM BECAME DISLODGED FROM THE REST OF THE PLASTIC GLENOSPHERE TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8361865 ↗