DELTA XTEND 1307-42-706Recalls & reported problems
Depuy Orthopaedics, Inc. · DELTA XTEND PREMIERON X-LINKED PE HUMERAL CUP HIGH MOBILITY SIZE 42 +6mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295027669), received between Aug 17, 2018 and Dec 21, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K091751, K120174); they may or may not involve this specific model.
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
- Device Dislodged or Dislocated2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Joint Dislocation2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Not Applicable1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISION DUE TO DISLOCATION. DOI: (B)(6), 2023, DOR: (B)(6), 2023, AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 18377879 ↗InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2017. DOR: (B)(6) 2021; LEFT SHOULDER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11497613 ↗InjuryAug 17, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. THE ORIGINAL 42MM STANDARD GLENOSPHERE WAS EXCHANGED FOR A 42MM ECCENTRIC GLENOSPHERE AND THE ORIGINAL SIZE 42 +6MM HIGH MOBILITY HUMERAL CUP WAS EXCHANGED FOR A SIZE 42 +6MM RETENTIVE HUMERAL CUP. DOI: (B)(6) 2018, DOR: (B)(6) 2018, LEFT SHOULDER.
Patient problems: Joint Dislocation; Not Applicable
MAUDE report 7792708 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K091751, K120174. One submission often covers many models, so check the product and lot details in each record.
- Z-0834-2018 · Aug 31, 2017 · TerminatedDELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with n
- Z-0833-2018 · Aug 31, 2017 · TerminatedDELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients wi
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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