DELTA XTEND 1307-20-113Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295510246), received between Mar 10, 2022 and Apr 10, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT HAD A FRACTURE CLAVICLE SO THE DOCTOR WANTED TO REMOVE THE GLENOSPHERE AND PROXIMAL PORTION OF THE STEM AND CONVERT TO A HEM SHOULDER UNTIL FRACTURE HEALED. THEY HAD TO WASTE PROXIMAL PART OF THE HUMERAL STEM AND CTA HEAD BECAUSE IT STILL PUT TO MUCH PRESSURE ON THE CLAVICLE. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 24843746 ↗
• InjuryDec 16, 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 INFECTION, SO SURGEON DECIDED TO REMOVED IMPLANTS AND PUT IN A HEMI SHOULDER. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 23815151 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF SHOULDER. ALL IMPLANTS REMOVED. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22717388 ↗
• InjuryJan 14, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT HAD REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2024, AND SUBSEQUENTLY HAD A FALL WHICH RESULTED IN THE SUTURE LINE OPENING AND THE WOUND BECOMING GROSSLY INFECTED. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025; REQUIRED DAIR AND THEN 1ST STAGE REVISION DUE TO EXTENT OF INFECTION AND LOOSENING OF COMPONENTS (EXPLANTATION AND WASHOUT AND THEN CEMENT SPACER).

  Patient problems: Fall; Inadequate Osseointegration; Unspecified Infection; Wound Dehiscence

  MAUDE report 21149056 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT SIDE: 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. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY :UNKNOWN, (B)(4). DEVICE PROPERTY OF :NONE, DEVICE IN POSSESSI

  Patient problems: Unspecified Infection

  MAUDE report 17050840 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. SURGEON DECIDED TO REMOVE THE CONSTRUCT AND IMPLANT AN ANTIBIOTIC SPACER. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 16517066 ↗
• InjuryDec 1, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PAIN AND STIFFNESS. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2022. (RIGHT SHOULDER). TREATMENT: CUP, GLENOSPHERE, AND EPIPHYSIS WERE REVISED.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 15892821 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE. THE STEM WAS REMOVED TO FIX THE FRACTURE AND A LONG MONOBLOC STEM WAS CEMENTED IN. NO OTHER INFORMATION. THERE WAS NO SURGICAL DELAY. THERE WAS NO LOOSENING REPORTED. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 15410907 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A DELTA XTEND DUE TO DISLOCATION AND INSTABILITY. THE PRIMARY SURGERY WAS DONE ABOUT 8 WEEKS AGO. DURING A PHYSIO REHAB SESSION THE PATIENT DISLOCATED. THE SURGEON WAS ABLE TO REDUCE THE SHOULD ONCE THE PATIENT WAS ASLEEP BUT WE STILL PROCEEDED WITH THE PLAN TO REVISE. ONLY THE 42+3 HMO CUP 1307-42-003 AND 145 EPIPHYSIS 1307-20113 WERE EXPLANTED SO THE CONSTRUCT COULD BE CONVERTED TO A 155 EPI AND 42+6 RETENTIVE CUP. THE SURGEON STATED THAT THE REASON FOR REVISION WAS NOT DUE TO ANY IMPLANT FAILURE, RATHER THE CHOICE OF IMPLANTS THAT WERE USED. SURGEON STATED HE SHOULD HAVE DONE A 155 IN THE FIRST PLACE WITH A STANDARD OR RETENTIVE CUP. THE PATIENT WAS ALSO QUITE A BIG BUILD, SO THE WEIGHT OF HIS ARM MIGHT HAVE GIVEN HIM A FALSE SENSE OF STABILITY.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 14949443 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS INFECTED. ALL IMPLANTS REMOVED. NO SURGICAL DELAY REPORTED. NO REPORTED LOOSENING. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 14345848 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT REVERSE TSA. IMPLANTING THE 16 SHORT STEM & EPI 145 RIGHT, THERE WAS A CRACK IN THE HUMERUS. THE HUMERUS WAS CERCLAGE AND A DECISION WAS MADE TO IMPLANT A STANDARD LENGTH STEM. IT IS ACKNOWLEDGED BY THE SURGEON THAT THERE ARE NOT SHORT STEM TRIALS AVAILABLE. THERE WAS A 40 MINUTES SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SHOULDER AFFECTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 13720078 ↗