Humelock II Cemented Shoulder System 311-0310Recalls & reported problems
Fx Solutions · HUMELOCK II STEM TA6V SIZE 10 CEMENTED · Class 2 · Implant
All models of Humelock II Cemented Shoulder System (9)
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 03701037301142), received between Mar 1, 2021 and May 15, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 Available1
- Device Dislodged or Dislocated1
- Loose or Intermittent Connection1
Patient problems
- Insufficient Information1
- Joint Laxity1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO DISMANTLING ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2020. A CUP, A GLENOSPHERE, A METAGLENE,A STEM AND SCREWS WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, A STEM, SMARTLOOP AND SCREWS WERE IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 16928946 ↗InjuryMar 1, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
PATIENT REVISED ON (B)(6) 2021 DUE TO A LOOSE HUMERAL STEM, APPROXIMATELY 3 MONTHS AFTER THE PRIMARY SURGERY . ACCORDING TO THE SURGICAL REPRESENTATIVE, THE HUMERAL STEM WAS LOOSE . THE SURGEON EXPLANTED THE SIZE 10 HUMELOCK II CEMENTED STEM AND THE 135/145 40/+3 STABILITY HUMERAL CUP AND THEN IMPLANTED A NEW SIZE 10 HUMELOCK II CEMENTED STEM, A 40/+6 STABILITY CUP, AND A 135/145 REVERSED ADAPTER FOR AN EXTRA +9MM OF SPACING.
Patient problems: Insufficient Information
MAUDE report 11391296 ↗
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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