Delta Xtend 1309-60-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295525189), received between Oct 13, 2022 and Sep 22, 2026 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860008 ↗
• InjuryMay 1, 2026Osseointegration Problem

  IT WAS REPORTED THAT PATIENT REVISED TO A HEMI CTA AFTER A FAILED REVERSE SHOULDER REVISION. PREVIOUSLY HAD AN ANATOMIC SHOULDER IN 2020. IT WAS STATED THAT METAGLENE BASEPLATE WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI - (B)(6) 2024. DOR - (B)(6) 2026. AFFECTED SIDE - RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25056849 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR DISPLACED TYPE 2B SCAPULAR SPINE FRACTURE. DEVICE (RELATEDNESS): PROBABLE. PROCEDURE (RELATEDNESS): CAUSAL RELATIONSHIP. DATE OF EVENT: 23 FEB 2023. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: SURGICAL INTERVENTION FOR THE REGISTRY SHOULDER: YES DATE OF SURGICAL INTERVENTION: (B)(6) 2026, OPEN REDUCTION INTERNAL FIXATION (ORIF): YES, COMPONENTS REMOVED (MARK NONE OR ALL THAT APPLY.) :( PLEASE COMPLETE A PATIENT COMPLETION/DISCONTINUATION FORMNBSP; NONE: YES. DEPUY SYNTHES PRODUCTS USED: TYPE: SCREW. CATALOG NUMBER: 130960315. LOT NUMBER: RL295828. DESCRIPTION: CENTRAL METAGLENE SCREW 6MM X 15MM. TYPE: SCREW. CATALOG NUMBER: 130790024. LOT NUMBER: 5547930. DESCRIPTION: DELTA XTEND LOCKING SCREW 4.5 X 24. TYPE: SCREW. CATALOG NUMBER: 130770018. LOT NUMBER: 5819790. DESCRIPTION: DELTA XTEND NON-LOCKING SCREW 4.5 X 18. TYPE: SCREW. CATALOG NUMBER: 130790024. LOT NUMBER: 5552950. DESCRIPTION: DELTA XTEND LOCKING SCREW 4.5 X 24. TYPE: SCREW. CATALOG NUMBER: 130770018. LOT NUMBER: 5829670. DESCRIPTION: DELTA XTEND NON-LOCKING SC

  Patient problems: Bone Fracture(s)

  MAUDE report 25034098 ↗
• InjuryJan 6, 2026Osseointegration Problem

  PATIENT WAS REVISED DUE TO INFECTION. IT WAS STATED THAT THE METEGLENE WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT INTERFACE. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 23976145 ↗
• InjuryAug 14, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH THIS WEDGE BASEPLATE DUE TO INSTABILITY AND IT MAY HAVE BEEN LOOSE. THERE WAS LOOSENING OF BASEPLATE AT NON BONE TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. THE SURGEON TOOK OUT BASEPLATE IN A STD BASEPLATE WITH CENTRAL SCREW, AND PUT IN NEW GLENOSPHERE, UPSIZED POLY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 22806494 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED POLY AND GLENOSPHERE. NO PROBLEMS, SURGERY WENT SMOOTH. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21880566 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. THERE WAS NO IMPLANT FAILURE, NO BROKEN IMPLANTS OR INSTRUMENTS. THE SURGEON SWAPPED THE GLENOSPHRE, POLY, AND COLLET ALL FOR SAME SIZES. THERE WAS NO DELAY AND NO COMPLAINT FROM THE SURGEON. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21772676 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND NEEDED MORE LATERALIZED IMPLANTS FOR STABILITY. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN SHOULDER SIDE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 21678372 ↗
• MalfunctionMar 13, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE GLENOSPHERE SCREW WOULD NOT LOCK INTO THE METAGLENE COLLET. EVERYTHING WAS IMPLANTED AND USED ACCORDING THE SURGICAL TECHNIQUE, BUT WHEN THE SURGEON WENT TO TIGHTEN THE SCREW INTO THE METAGLENE IT ACTED AS IF IT WAS STRIPPED. A GOOD BITE WAS NOT ATTAINABLE AND THE SCREW WOULD JUST KEEP SPINNING AND NOT ENGAGE INTO THE COLLET. ANY EXCESS BONE WAS REMOVED AROUND THE METAGLENE, SO THE SURGEON DID NOT SEE ANY INTERFERENCE WITH THE HEAD. THE GLENOSPHERE HAD GOOD FIXATION VIA THE MORSE TAPER ONTO THE METAGLENE, SO THE SURGEON LEFT IT AS THAT WITHOUT TIGHTENING THE SCREW.

  Patient problems: Insufficient Information

  MAUDE report 18892937 ↗
• 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 18685489 ↗
• 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 18229577 ↗
• MalfunctionNov 13, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT UPON SCREWING THE GLENOSPHERE INTO THE COLLET AND METAGLENE, THE SURGEON GOT THE TACTILE FEEL THAT THE SCREW WOULD TIGHTEN AND THEN ONCE IT REACHED A CERTAIN TIGHTNESS WOULD RELEASE AND FEEL AS IF NOT THREADED AT ALL. SURGICAL DELAY UNKNOWN. DOE: (B)(6) 2023 AFFECTED SIDE: UNKNOWN SHOULDER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118376 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL SURGERY ON (B)(6) CONVERTED A UNITE ANATOMIC TSA TO A REVERSE TSA. THE PATIENT BECAME UNSTABLE AND DISLOCATED IN LAST FEW WEEKS. DURING REVISION IT WAS DISCOVERED THE EPI WAS NOT COMPLETELY LOCKED DOWN AND HAD ROTATED. SURGEON REMOVED ALL DEPUY COMPONENTS AND WENT BACK WITH ARTHREX WHICH HE USES REGULARLY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 17343775 ↗
• 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 16112314 ↗
• MalfunctionDec 6, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE COLLET AND THE GLENOSPHERE SCREW WOULD NOT PROPERLY ENGAGE. THE SCREW WOULD ONLY TURN BUT WILL NOT LOCK. NO SURGICAL DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925046 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 15599908 ↗