DELTA XTEND 130748026Recalls & reported problems
Depuy (Ireland) · DELTA Xtend CTA Head Dia 48 x 26 mm · Class 2 · Implant
All models of DELTA XTEND (194)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295027706), received between Nov 8, 2017 and Mar 25, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
10 other recalls cover devices cleared under the same FDA submission (K062250, K120174, K192855); 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
Patient problems
- Pain3
- Unspecified Infection2
- Joint Laxity1
- Unspecified Tissue Injury1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT'S IMPLANTS WERE REVISED TO CONVERT TO A REVERSE BECAUSE OF CUFF TEAR. DOI: UNKNOWN. DOR: (B)(6). AFFECTED SIDE- UNKNOWN SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 24692018 ↗InjuryDec 12, 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 PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.
Patient problems: Pain
MAUDE report 23788847 ↗InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT COMPLAINING OF PAIN. CONCERNED CTA HEMI TO A REVERSE TSA. STEM WAS RETAINED AFTER FOUND TO BE WELL FIXED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN; DOR- (B)(6) 2023; AFFECTED SIDE- RIGHT SHOULDER.
Patient problems: Pain
MAUDE report 17050365 ↗InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
PATIENT WAS REVISED DUE TO CHRONIC INFECTION, PAIN, HEALTH ISSUES AND MULTIPLE FALLS, THE IMPLANT WERE REMOVED. NO OTHER INFORMATION. NO SURGICAL DELAY WAS THERE. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Pain; Unspecified Infection
MAUDE report 15987535 ↗InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S SHOULDER WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT SHOULDER.
Patient problems: Joint Laxity
MAUDE report 13045386 ↗InjuryNov 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT WAS REVISED TO ADDRESS INFECTION.
Patient problems: Unspecified Infection
MAUDE report 7009599 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K062250, K120174, K192855. 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
- Z-0534-2009 · Jul 10, 2008 · TerminatedDepuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+9 STD, sterile, Depuy France; REF 130738209. The device is used as a shoulder implant.
- Z-0535-2009 · Jul 10, 2008 · TerminatedDepuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+6R RET, sterile, Depuy France; REF 130738106. The device is used as a shoulder implant.
- Z-0537-2009 · Jul 10, 2008 · TerminatedDepuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+6 STD, sterile, Depuy France; REF 130742206. The device is used as a shoulder implant.
- Z-0536-2009 · Jul 10, 2008 · TerminatedDepuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+3 STD, sterile, Depuy France; REF 130742203. The device is used as a shoulder implant.
- Z-0539-2009 · Jul 10, 2008 · TerminatedDepuy DELTA Xtend, Standard Humeral PE Cup, Dia 42+6R RET, sterile, Depuy France; REF 130742106. The device is used as a shoulder implant.
- Z-0533-2009 · Jul 10, 2008 · TerminatedDepuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 130738206. The device is used as a shoulder implant.
- Z-0538-2009 · Jul 10, 2008 · TerminatedDepuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+9 STD, sterile, Depuy France; REF 130742209. The device is used as a shoulder implant.
- Z-0532-2009 · Jul 10, 2008 · TerminatedDepuy DELTA Xtend, Standard humeral PE Cup Dia 38/+3 STD, sterile, Depuy France; REF 130738203. The device is used as a shoulder implant.
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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