HUMELOCK REVERSED 317-3612Recalls & reported problems
Fx Solutions · HUMELOCK REVERSED STEM TA6V Ø36/12 CEMENTLESS LOCKABLE Ti/HA · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03701037303740), received between Jan 28, 2022 and Jun 9, 2026 — classified as 7 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Appropriate Device Problem Term/Code Not Available2
- Device Dislodged or Dislocated1
- Naturally Worn1
Patient problems
- Medical device site infection4
- Insufficient Information2
- Joint Dislocation1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2026. THE IMPLANTATION DATE WAS ON (B)(6) 2026. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS AND A STEM WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 25441345 ↗InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2026. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS AND A STEM WERE EXPLANTED. WITHOUT REPLACEMENT.
Patient problems: Medical device site infection
MAUDE report 25135524 ↗InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2026. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS AND A STEM WERE IMPLANTED. PATIENT WITH KORSAKOFF'S SYNDROME DOES NOT REMEMBER WHAT CAUSED THE DISLOCATION
Patient problems: Joint Dislocation
MAUDE report 25091464 ↗InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS AND A STEM WERE EXPLANTED.
Patient problems: Medical device site infection
MAUDE report 23437134 ↗InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS AND A STEM WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 22008508 ↗InjuryJan 28, 2022Device Dislodged or Dislocated; Naturally Worn; Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2021, APPROXIMATELY 11 MONTHS AFTER THE PRIMARY SURGERY ON (B)(6) 2021. THE REVISION WAS DUE TO DISLOCATION RESULTING FROM THE WEAR & TEAR IN THE HUMERAL CUP. THE SURGEON EXPLANTED THE STANDARD HUMERAL CUP (36/+3) AND IMPLANTED A STABILITY HUMERAL CUP (36/+6).
Patient problems: Insufficient Information
MAUDE report 13385380 ↗InjuryJan 28, 2022Appropriate Device Problem Term/Code Not Available
THE REVISION SURGERY WAS PERFORMED AS THE PATIENT WAS EXPERIENCING INSTABILITY ON (B)(6) 2021, APPROXIMATELY 6 MONTHS AFTER PRIMARY SURGERY ON (B)(6) 2021. THE GLENOID BASEPLATE (24MM), CENTERED GLENOSPHERE (36MM), HUMERAL CUP (36/3) AND CORTICAL SCREW (26MM), WERE EXPLANTED EXCEPT FOR THE HUMELOCK REVERSED CEMENTLESS STEM (36/12). A GLENOID BASEPLATE (24MM), CENTERED GLENOSPHERE (36MM), HUMERAL CUP (36/3), CENTRAL SCREW (16MM) AND LOCKING SCREWS (15MM, 2 EACH OF 30MM AND 35MM) WERE IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 13384839 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page