Delta Xtend 1309-70-850Recalls & reported problems
Depuy (Ireland) · Delta Xtend REVERSE SHOULDER SYSTEM AUGMENTED CENTRAL SCREW METAGLENE FULL WEDGE · Class 2 · Implant
All models of DELTA XTEND (194)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295525332), received between Nov 13, 2023 and Apr 29, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Contaminated During Manufacture or Shipping1
- Difficult to Insert1
- Osseointegration Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Bone Fracture(s)1
- Inadequate Osseointegration1
- Joint Laxity1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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: (B)(6) 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 FORM & NBSP; NONE: YES. DEPUY SYNTHES PRODUCTS USED: TYPE: SCREW, CATALOG NUMBER: 130960315, LOT NUMBER: RL295828, DESCRIPTION: CENTRAL METAGLENE SCREW 6 MM X 15 MM. 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
Patient problems: Bone Fracture(s)
MAUDE report 25034130 ↗MalfunctionDec 4, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE PEEL PACK WRAP TORE UNEVENLY WHEN IT WAS PASSED INTO THE STERILE FIELD. THE IMPLANT WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715008 ↗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 22806490 ↗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: ON (B)(6) 2023. AFFECTED SIDE: UNKNOWN SHOULDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18118379 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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