DELTA XTEND 1307-64-142Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295502463), received between Mar 15, 2021 and Jul 10, 2026 — classified as 9 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (9 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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR LOOSENING AND INFECTION. IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO HUMERAL STEM LOOSENING AT BONE TO CEMENT INTERFACE. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 25778428 ↗
• InjuryJun 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAS HAD MULTIPLE FALLS AND THE GLENOSPHERE DISASSOCIATED FROM THE BASE PLATE. POLY WAS DEFORMED FROM RUBBING AGAINST BASEPLATE. DOCTOR DECIDED THAT A CTA HEAD WOULD BE THE BEST CHOICE FOR THIS PATIENT. TOOK OUT POLY, GLENOSPHERE, BASEPLATE, AND SCREWS AND REPLACED WITH THE CTA HEAD. IT WAS STATED THAT THE LOOSENING OF SHOULDER GLENOSPHERE WAS UNKNOWN. DOI: UNKNOWN DOR: (B)(6), 2026 AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 25433246 ↗
• MalfunctionMar 25, 2026Difficult to Insert

  IT WAS REPORTED THAT INTRAOPERATIVELY DURING SHOULDER SURGERY, IT WAS NOT POSSIBLE TO FIX BOTH GLENOSHERES IN THE METAGLENE. ANOTHER GLENOSPHERE WAS USED AS A THIRD ATTEMPT AND THE SURGERY WAS COMPLETED. THERE WAS LESS THAN 10 MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691223 ↗
• MalfunctionMar 25, 2026Difficult to Insert

  IT WAS REPORTED THAT INTRAOPERATIVELY DURING SHOULDER SURGERY, IT WAS NOT POSSIBLE TO FIX BOTH GLENOSHERES IN THE METAGLENE. ANOTHER GLENOSPHERE WAS USED AS A THIRD ATTEMPT AND THE SURGERY WAS COMPLETED. THERE WAS LESS THAN 10 MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691165 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23790845 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF REVERSE LEFT SHOULDER DUE TO INFECTION. THIS REPORT IS RELATED COMPLAINT (B)(4) WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 23569949 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS COMPLAINING OF HUMERAL PAIN. STEM WAS FOUND TO BE IN GOOD STABLE CONDITION AS WELL AS METAGLENE. SURGEON REPLACED SCREWS, GLENOSPHERE AND PLOY TO BIGGER SIZES TO GIVE MORE STABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23488232 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INSTABILITY. THE PATIENT HAD REPORTED NO INSTABILITY DURING THE FIRST FEW YEARS AND WAS SATISFIED WITH THE RESULTS UNTIL EXPERIENCING ISSUES OVER THE PAST 6 MONTHS. TO ACHIEVE APPROPRIATE STABILITY, THE SURGEON UPSIZED THE GLENOSPHERE AND HUMERAL CUP. THERE WERE NO PATIENT CONSEQUENCES AND NO SURGICAL DELAY OCCURRED. DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22751472 ↗
• MalfunctionJul 19, 2024Difficult to Insert; Difficult to Insert

  INTRAOPERATIVE IT WAS NOT POSSIBLE TO ENGAGE THE GLENOSPHERE WITH THE METAGLENE. ANOTHER IMPLANT WAS USED. THIS WAS POSSIBLE WITHOUT ISSUES. A SURGICAL DELAY WAS NOT REPORTED, NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781798 ↗
• MalfunctionFeb 15, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT IT IS DIFFICULT TO ENGAGE THE SCREWS OF THE TWO GLENOSPHERES WITH THE THE METAGLENE. SURGICAL DELAY ABOUT TEN MINUTES, NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710639 ↗
• MalfunctionFeb 12, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT INTERIOR SCREW OF GLENOSPHERE WOULD NOT ENGAGE INTO COLLET. WOULD THREAD AND ENGAGE BUT WOULD RELEASE ONCE MORE TORQUE WAS APPLIED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN, DOR- ON (B)(6) 2024, AFFECTED SIDE- UNKNOWN SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685479 ↗
• MalfunctionNov 29, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING IMPLANTATION OF GLENOSPHERE INTO METAGLENE SURGEON FELT TIGHTENING OF THE SCREW INTO THE COLLET THEN THE FEELING IT HAD RELEASED. REPEATED THE PROCESS AGAIN WITH SAME RESULT. ULTIMATELY FELT SCREW TIGHTEN INTO COLLET AND MOVED ON WITH PROCEDURE. NO TIME DELAY. AFFECTED SIDE: LEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229588 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A DELTA XTEND DUE TO INFECTION. THE PATIENT HAD A PREVIOUS REVISION SURGERY A FEW YEARS AGO. UNABLE TO CONFIRM EXACT DATE. REASON FOR THIS WAS DUE TO GLENOID NOTCHING AND PAIN. AT THIS REVISION THE 155 EPI WAS REMOVED, GLENOID WAS REMOVED. UNSURE IF THE METAGLENE AND SCREWS WERE TOO. THE STEM WAS RETAINED, AND IT WAS CONVERTED TO A 145 EPI WITH LATERALISED GLENOSPHERE. PATIENT NOTES WERE UNAVAILABLE TO CONFIRM EXACT DATES AND LOT NUMBERS. I'M UNABLE TO CONFIRM WHAT PC THIS WAS LOGGED AGAINST TOO. TODAY WE REMOVED ALL IMPLANTS AS PER IMPACTED PRODUCTS. 4X SCREWS WERE ALSO REMOVED, BUT I'M UNABLE TO CONFIRM THE REF AND LOT NUMBERS FOR THESE. A SPACER WAS IMPLANTED UNTIL THE INFECTION CLEARS. DOI: UNKNOWN, DOR; (B)(6) 2023, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 17059069 ↗
• MalfunctionJan 6, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT UPON INSERTION OF THE GLENOSPHERE INTO THE METAGLENE, THE SCREW WOULD NOT PROPERLY TIGHTEN INTO THE COLLET. SCREW WOULD TIGHTEN AND THEN SLIP AND BECOME LOOSE AFTER SUFFICIENT FORCE TO TIGHTEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112309 ↗
• InjuryApr 18, 2022Difficult to Insert; Difficult to Insert

  THE POST ON GLENOSPHERE WASN'T SEATING IN METAGLENE. DOE: (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14138825 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. REVISION FOR INFECTION - WAS THERE ANY SUGGESTION BY ANYONE INDICATING THAT THERE WAS OR MAY BE DEFICIENCY WITH THE PRODUCT(S)? IF YES, PLEASE PROVIDE DETAILS. THE SURGEON DID NOT NOTE ANY DEFICIENCY WITH THE IMPLANTS CAUSING THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 12843880 ↗
• MalfunctionMar 15, 2021Difficult to Insert; Difficult to Insert

  INTRAOPERATIVELY DURING PRIMARY SHOULDER-TEP RIGHT SIDE IT WAS NOT POSSIBLE TO CONNECT THE GLENOSPHERE TO THE METAGLENE. ANOTHER GLENOSPHERE WAS AVAILABLE AND PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM, NO ADVERSE CONSEQUENCES. SURGICAL DELAY < 10 MIN.

  Patient problems: Insufficient Information

  MAUDE report 11486115 ↗