DELTA XTEND 1307-62-142Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295502500), received between May 12, 2020 and Mar 10, 2026 — classified as 17 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (8 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

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

  PATIENT WAS REVISED DUE TO IMPINGEMENT. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 24560232 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHOULDER REVISED FOR BASEPLATE LOOSENING DUE TO INFECTION. 48MM ANTIBIOTIC SPACER IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24494237 ↗
• InjuryFeb 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT GLENOSPHERE DISSOCIATED FROM BASEPLATE. THERE WAS LOOSENING OF GLENOSPHERE AT UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS ALSO UNKNOWN. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 24270306 ↗
• InjuryOct 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE DISLOCATION. THIS IS A POST OP EVENT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 23248737 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SHOULDER BECAME INFECTED AND HARDWARE NEEDED TO BE REMOVED. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22160871 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22015160 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REMOVAL OF IMPLANTS DUE TO INFECTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. ACTIVITY LEVEL - YES. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21069287 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD WASHED OUT AND COMPONENTS CHANGED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN SHOULDER SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 20268911 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND WEAR. SCAPULAR NOTCHING APPARENT ON X-RAY. REVISED TO MORE LATERALIZATION ON GLENOSPHERE AND ECCENTRICITY. DOI: (B)(6) 2022 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 19646098 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY DONE (B)(6) 2022 AT HOSPITAL. UNFORTUNATELY THE BASEPLATE AND GLENOSPHERE COMPONENTS BECAME LOOSE. THE HUMERAL COMPONENTS WERE FOUND TO BE WELL FIXED AND STABLE. SURGEON FELT THE PATIENT WOULD BENEFIT FROM A THOROUGH WASHOUT OF THEIR SHOULDER AND A REVISION OF THEIR GLENOID COMPONENTS. ONCE IMPLANTS WERE REMOVED AND THE SHOULDER WAS WASHED, THE GLENOID WAS PREPPED FOR AN INHANCE BASEPLATE. A TRIAL REDUCTION WAS PERFORMED WITH A 40 +8 ECCENTRIC GLENOSPHERE AND A 42 +6R POLY ON THE DELTA HUMERAL SIDE. SURGEON WAS OK WITH THE MISMATCH OF GLENOSPHERE TO POLY DUE TO NOT WANTING TO REVISE THE WELL FIXED HUMERAL COMPONENT. THE SHOULDER WAS FOUND TO BE STABLE, SO FINAL IMPLANTS WERE OPENED AND INSERTED. STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. THERE WAS NO ADVERSE EVENTS OR DELAYS TOOK PLACE. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 19319594 ↗
• MalfunctionApr 26, 2024Difficult to Insert; Difficult to Insert

  INTRAOPERATIVE IT WAS NOT POSSIBLE TO ENGAGE THE GLENOSPHERE WITH THE METAGLENE. A STANDARD GLENOSPHERE 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 19197113 ↗
• MalfunctionApr 3, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON OPENED STANDARD METAGLENE IN A REVERSE SHOULDER AND IMPLANTED IT. THEN OPENED A GLENOSPHERE TO ATTACH TO METEGLENE. THE GLENOSPHERE WOULD NOT ADVANCE AS IF SOMETHING WAS STOPPING THREADS. A NEW BASEPLATE METAGLENE WAS OPENED AND STILL NO ADVANCEMENT WOULD HAPPEN. A NEW GLENOPHERE WAS OPENED AND WITH NEW METAGLENE AND GLENOSPHERE THE IMPLANTS WERE SUCCESSFULLY SEATED. IT IS THOUGHT THAT THREADS IN FIRST IMPLANTED METAGLENE WERE DAMAGED AND THAT IS WHY GLENOSHERE WOULD NOT SEAT. THIS THEN DAMAGED THE GLENOSPHERE THREADS SURGERY DELAYED 15 MINUTES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19030794 ↗
• MalfunctionMar 20, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT GLENOSPHERE WAS NOT FULLY SEATED. DOI:(B)(6) 2024. DOE: MARCH 12, 2024. AFFECTED SIDE- LEFT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942167 ↗
• 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 METAGLENE. SURGICAL DELAY ABOUT TEN MINUTES, NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710616 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELT UNSTABLE. DOI: (B)(6) 2021 DOR: (B)(6) 2023 AFFECTED SIDE: LEFT SHOULDER

  Patient problems: Joint Laxity

  MAUDE report 18073642 ↗
• InjuryJul 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 17267895 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 17191604 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF PAIN FROM ORIGINAL SURGERY. SURGEON TOOK A CT TO DETERMINE IF THERE WAS ANY NOTCHING AND DIDN¿T NOTICE ANYTHING UNUSUAL EXCEPT THAT THE SUPERIOR SCREW MAY BE TOO LONG. THE SURGEON TOOK CULTURES DURING THE CASE TO RULE OUT INFECTION. THERE WAS NO NOTICEABLE POLY WEAR AND NO NOTICEABLE SCAPULAR NOTCHING WHEN RETRIEVING THE IMPLANTS. THE SURGEON DECIDED TO SWITCH OUT THE SUPERIOR SCREW FOR A SHORTER 18 NON LOCKER AND REPLACED GLENOSPHERE WITH A MORE LATERALIZED ECCENTRIC OPTION. SURGEON SAID THAT HE HAD A GOOD RANGE OF MOTION WITH THE NEW COMBINATION. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 15950325 ↗
• MalfunctionMay 12, 2022Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THAT THE GLENOSPHERE CROSS THREADED AND WOULD NOT SCREW ON THE BASEPLATE. METAL SHAVINGS WERE COMING FROM THE THREADS OF THE CENTRAL PEG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14372424 ↗
• MalfunctionJul 16, 2021Difficult to Insert; Off-Label Use; Difficult to Insert; Off-Label Use

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO KNOWN CONSEQUENCES TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 12181565 ↗
• InjuryJun 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD DISLOCATION. THERE WAS NO LOOSENING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 11935054 ↗
• MalfunctionSep 28, 2020Difficult to Insert; Difficult to Insert

  05 OCT 2020: ADDITIONAL INFORMATION WAS RECEIVED FROM G. PADILLA, SALES REP, ON SEPTEMBER 30,2020 AT 6:22 PM STATING "THIS WAS MY CASE THAT I COVERED. HE HAD AN ISSUE WITH SHORT POST. I HAD TWO OF THE POSTS CROSS THREAD. HE USED A GUIDE WIRE TO SEAT THE GLENOSPHERE.".

  Patient problems: No Code Available

  MAUDE report 10594092 ↗
• MalfunctionAug 20, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE GLENOSPHERE WOULD NOT MATE WITH THE METAGLENE. THIS WAS TRIED MULTIPLE TIMES AND THE INTERNAL SCREW IN PIECE WOULD NOT ENGAGE WITH THE METAGLENE. NO FAULT OF THE SURGEON. THERE WAS A SURGICAL DELAY OF 30 MINS.

  Patient problems: No Code Available

  MAUDE report 10434223 ↗
• InjuryJul 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2020 DOR: (B)(6) 2020 RIGHT SHOULDER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10330031 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: 1. IMPLANT INSERTION OP NOTES. REASON FOR INITIAL ARTHROPLASTY- PATIENT HAD A FAILED ROTATOR CUFF REPAIR OF A VERY LARGE TEAR AND NOW HAD AN IRREPARABLE TEAR WITH EARLY GLENOHUMERAL ARTHROPATHY. PAIN WAS SEVERE AND FUNCTION LIMITED. THERE ARE NO PT REPORTS SINCE PATIENT WAS REHABBING WITH HOME EXERCISE AND THERE WERE NO REPORTED FALLS OR DISLOCATION EVENTS. 2. IMPLANT REMOVAL/REVISION OP NOTES. REASON FOR REVISION SURGERY- A LARGE POST-OPERATIVE HEMATOMA BECAME ERYTHEMATOUS AND PURULENT MATERIAL BEGAN DRAINING FROM INCISION. DUE TO INFECTION PATIENT WAS IRRIGATED AND DERIDED. THERE WAS A SMALL AREA WHERE THIS INFECTION HAD BEGUN TO INFILTRATE THE JOINT. SINCE THE INTRAARTICULAR FLUID WAS NOT PURULENT AND THE HUMERAL STEM AND METAGLENE WELL FIXED, THE GLENOSPHERE AND POLY CUP WERE REMOVED AND NEW COMPONENTS PLACED.

  Patient problems: Hematoma; No Code Available; Unspecified Infection

  MAUDE report 10049464 ↗