DJO SURGICAL 504-46-022Recalls & reported problems
Encore Medical, L.P. · HEAD, HUMERAL W/OFFSET FEMALE TAPER, 46X22 O/S · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912143714), received between Sep 4, 2015 and Aug 19, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
- Appropriate Device Problem Term/Code Not Available1
- Device Operates Differently Than Expected1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Code Available2
- Bone Fracture(s)1
- Injury1
- Loss of Range of Motion1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 26, 2016Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO LOSS OF MOTION, REQUIRING INTERVENTION. THE SURGEON REMOVED 506-06-000 AND 504-46-022.
Patient problems: Loss of Range of Motion
MAUDE report 6057546 ↗InjuryJan 22, 2016Device Operates Differently Than Expected
REVISION SURGERY - DUE TO THE PATIENT'S CUFF FAILING AND NEEDING TO BE REVISED TO A REVERSE SHOULDER.
Patient problems: No Code Available
MAUDE report 5385348 ↗InjurySep 4, 2015Improper or Incorrect Procedure or Method
REVISION SURGERY: NON COMPLIANT PATIENT. THE PATIENT HAS HAD 2 SUB SCAP REPAIRS SINCE THE ORIGINAL SHOULDER REPLACEMENT DUE TO OPERATING POWER TOOLS AND LIFTING OBJECTS ABOVE HER HEAD. THE PATIENT ONCE AGAIN INJURED HERSELF AND THIS SUB SCAP COULD NOT BE REPAIRED WELL, SO THE SURGEON DECIDED TO GO WITH A REVERSE SHOULDER PROSTHESIS.
Patient problems: Injury; No Code Available
MAUDE report 5058128 ↗
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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