DJO SURGICAL 500-04-142Recalls & reported problems
Encore Medical, L.P. · GLENOID, UNIFORM, PEGGED 42MM CM FOUNDATION SHOULDER · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912143196), received between Mar 3, 2016 and Jul 14, 2021 — classified as 5 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
Patient problems
- Failure of Implant2
- No Code Available2
- Osteolysis1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJul 14, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAS OSTEOLYSIS AND THE GLENOID FAILED SO SURGEON REMOVED THE TOTAL SHOULDER AND REVISED TO A REVERSE TOTAL SHOULDER.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 12170147 ↗InjuryMar 31, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - FAILED TOTAL SHOULDER PATIENT HAS HAD FOR 13 YEARS.
Patient problems: Failure of Implant
MAUDE report 9905450 ↗InjurySep 25, 2018Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT'S SHOULDER BEING INFECTED. THE SURGEON REMOVED THE COMPONENTS AND IMPLANTED CEMENT SPACERS.
Patient problems: Unspecified Infection
MAUDE report 7907480 ↗InjuryMay 21, 2018Loose or Intermittent Connection
REVISION SURGERY - DUE TO GLENOID LOOSENING. THE SURGEON REMOVED EVERYTHING AND REVISED TO A REVERSE TOTAL SHOULDER.
Patient problems: No Code Available
MAUDE report 7531401 ↗InjuryMar 3, 2016Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT HAD A FOUNDATION SHOULDER STEM IN, NO GLENOID COMPONENT . PATIENT PRESENTED WITH ROTATOR CUFF ARTHROPATHY AND WAS IN NEED OF A REVERSE. THE STEM WAS TAKEN OUT TO IMPLANT A REVERSE STEM AND GLENOID, THERE WAS NO IMPLANT FAILURE. DJO IMPLANTS WERE NOT REIMPLANTED.
Patient problems: No Code Available
MAUDE report 5477578 ↗
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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