DELTA XTEND 1307-62-138Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295502494), received between Aug 27, 2019 and Apr 10, 2026 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  REMOVAL OF SHOULDER COMPONENTS DUE TO DEEP INFECTION OF THE LEFT SHOULDER JOINT. DEVICES WERE DISCARDED.

  Patient problems: Unspecified Infection

  MAUDE report 24839395 ↗
• InjuryOct 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATING SHOULDER. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 23310558 ↗
• InjuryJul 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22590629 ↗
• InjuryMar 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISLOCATION - SOME OSTEOPHYTES BUT THE SURGEON COMMENTED HE SHOULD HAVE LATERALISED MORE AS PER MATERIALISE PLAN. SURGEON LATERALISED THE GLENOSPHERE AN EXTRA 2MM (ORIGINALLY 2MM AND LATERALISED TO 4MM) ALSO REPLACED +3/38MM POLY TO +6 RETENTIVE / 38MM. THERE WAS NOTHING WRONG WITH THE PRODUCTS; THE PATIENT'S ANATOMY OF THE SCAPULAR NECK WAS IMPINGING ON THE ORIGINAL GLENOSPHERE SO BY LATERALISING AND UPSIZING THE CUP, THERE WAS NO IMPINGEMENT. THE PATIENT HAD DISLOCATED 3 TIMES, WITH MUA THE FIRST TWO TIMES AND REVISION SURGERY THE THIRD TIME. THE SHOULDER WAS DISLOCATING DUE TO HAVING OSTEPHYTES PRESENT STILL AS WELL AS NOT BEING LATERAL ENOUGH, AND THE IMPLANTS WERE IMPINGING ON THE NECK OF THE HUMERUS. AFFECTED SIDE: LEFT.

  Patient problems: Joint Dislocation

  MAUDE report 21631852 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SUSPECTED LEFT SHOULDER INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21607212 ↗
• InjuryJun 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED AND WAS NOT ABLE TO BE REDUCED IN THE CLINIC. SHE WAS BROUGHT TO THE OR TO OPEN AND REDUCE. ALL COMPONENTS WERE WELL FIXED. THE GLENOSPHERE WAS INCREASED TO A 42+2 STD AND A 42 + 6 RETENTIVE LINER WAS USED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 19479464 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING WAS EXPLANTED AND A SPACED WAS PUT IN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19384328 ↗
• MalfunctionNov 30, 2023Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THE ADVERSE EFFECT WAS UNKNOWN. IT ALSO STATES THAT THERE WERE NO ALLEGATIONS OF SCREWDRIVER.

  Patient problems: Insufficient Information

  MAUDE report 18236093 ↗
• MalfunctionNov 30, 2023Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THE ADVERSE EFFECT WAS UNKNOWN. IT ALSO STATES THAT THERE WERE NO ALLEGATIONS TO SCREW DRIVER.

  Patient problems: Insufficient Information

  MAUDE report 18236092 ↗
• InjuryNov 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO SHOULDER DISLOCATION AFTER SURGERY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 15734323 ↗
• MalfunctionSep 8, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE GLENOSPHERE WOULD NOT SEAT ONTO METAGLENE. THERE WAS NO LOOSENING. THERE WAS SURGICAL DELAY OF 1 HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380132 ↗
• InjuryJul 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS A RECENT DISLOCATION. THE PATIENT HAD A PRIOR REVERSE CONSTRUCT FOR FRACTURE. DOI: (B)(6) 2021. DOR: (B)(6) 2021. RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 12121702 ↗
• InjuryMar 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATED REVERSE SHOULDER IN HOSPITAL BED. INITIAL SURGERY WAS FOR A 4 PART PROXIMAL HUMERAL FRACTURE. DOI: (B)(6) 2021 DOR: (B)(6) 2021 RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 11553980 ↗
• MalfunctionAug 27, 2019Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 38MM +2 LATERALIZED GLENOSPHERE WOULD NOT SEAT IN THE METAGLENE AFTER MULTIPLE INSERTION ATTEMPTS. SUBSEQUENTLY, A STANDARD 38 GLENOSPHERE WAS INSERTED ON THE FIRST ATTEMPT WITHOUT ISSUE. DOE: (B)(6) 2019, LEFT SHOULDER.

  Patient problems: Not Applicable

  MAUDE report 8934943 ↗