Delta Xtend 1309-60-000Recalls & reported problems
Depuy (Ireland) · Delta Xtend REVERSE SHOULDER SYSTEM CENTRAL SCREW METAGLENE STANDARD · 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 10603295525196), received between Nov 29, 2023 and May 1, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Osseointegration Problem” (2 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.
Reports received per month
Most reported problems
Device problems
- Osseointegration Problem2
- Difficult to Advance1
- Difficult to Insert1
- Material Deformation1
Patient problems
- Inadequate Osseointegration2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 25056914 ↗InjuryFeb 25, 2026Osseointegration Problem
IT WAS REPORTED THAT FAILED GLENIOD DISTAL STEM LEFT IN PLACE. IT WAS STATED THAT BASE PLATE AND SCREWS WERE LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Inadequate Osseointegration
MAUDE report 24443217 ↗MalfunctionSep 4, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation
IT WAS REPORTED THAT THERE WERE MAJOR ISSUES WITH THE COLLET NOT ALLOWING GLENOSPHERE SCREW TO THREAD. THE COLLET EXTRACTION TOOL ALSO WOULDN'T FIT INTO THE HOLE. HAD TO USE A DENTAL PICK TO RIP IT OUT. SURGEON WAS FRUSTRATED AND ENDED UP WASTING THE COLLETT, STD CSM BASEPLATE, AND 15 CENTRAL SCREW AND PUTTING IN LEGACY BASEPLATE +10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22961549 ↗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 18229575 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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