Humelock Reversed Shoulder 313-3206Recalls & reported problems
Fx Solutions · HUMELOCK REVERSED STEM TA6V CEMENTED Ø32/06 · Class 2 · Implant
All models of Humelock Reversed Shoulder (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03701037301388), received between Feb 19, 2021 and Jul 27, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth1
- Unstable1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Subluxation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2023Unstable; Unstable
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2022. A GLENOSPHERE AND A STEM WERE EXPLANTED. A GLENOSPHERE, A DIAPHYSEAL PLATE AND A STEM WERE IMPLANTED.
Patient problems: Subluxation
MAUDE report 17404305 ↗InjuryFeb 19, 2021Loosening of Implant Not Related to Bone-Ingrowth
REVISION : LOOSENING STEM. SURGEON REMOVED CEMENTED STEM AND REPLACED BY AN OTHER CEMENTED STEM.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11347876 ↗
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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