Humelock II Cemented Reversible Shoulder 313-0709Recalls & reported problems
Fx Solutions · HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +9 · Class 2 · Implant
All models of Humelock II Cemented Reversible Shoulder (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03701037301371), received between Feb 26, 2021 and Nov 12, 2024 — classified as 11 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).
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
- Appropriate Device Problem Term/Code Not Available4
- Adverse Event Without Identified Device or Use Problem3
- Device Dislodged or Dislocated3
- Break1
- Improper or Incorrect Procedure or Method1
- Migration1
- Unstable1
Patient problems
- Joint Dislocation4
- Joint Laxity2
- Failure of Implant1
- Insufficient Information1
- Subluxation1
- Unspecified Infection1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2024Improper or Incorrect Procedure or Method; Migration; Improper or Incorrect Procedure or Method; Migration
THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2024. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 20662558 ↗InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2020. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP, A GLENOSPHERE AND A REVERSED ADAPTER WERE IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 19150782 ↗InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT DISLOCATED DUE TO JOINT INSTABILITY. HUMERAL CUP SWAP PERFORMED. STANDARD HUMERAL CUP 36 MM + 9 EXPLANTED AND REPLACED WITH STANDARD HUMERAL CUP 36 MM + 6.
Patient problems: Joint Laxity
MAUDE report 17941677 ↗InjuryMay 29, 2023Unstable; Unstable
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6)2023. A CUP, A GLENOSPHERE AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE AND A STEM WERE IMPLANTED.
Patient problems: Subluxation
MAUDE report 17016475 ↗InjuryApr 8, 2022Device Dislodged or Dislocated
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO DISLOCATION FOLLOWING THE PRIMARY SURGERY ON (B)(6) 2022. THE SURGEON EXPLANTED A HUMERAL CUP (36/9) AND IMPLANTED A REVERSE ADAPTER AND A STABILITY HUMERAL CUP (36/6).
Patient problems: Joint Dislocation
MAUDE report 14056675 ↗InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO DISLOCATION. APPROXIMATELY 14 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP (36/9). THE SURGEON IMPLANTED 1 HUMERAL CUP (36/6) AND 1 REVERSE ADAPTER.
Patient problems: Joint Dislocation
MAUDE report 13993303 ↗InjuryMar 28, 2022Break; Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 FOR DISMANTLING. APPROXIMATELY 13 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP (36/9). THE SURGEON IMPLANTED 1 HUMERAL CUP (36/9).
Patient problems: Insufficient Information
MAUDE report 13926277 ↗InjuryMar 25, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INFECTION. APPROXIMATELY 1 YEAR AND 4 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP 36/9. THE SURGEON IMPLANTED 1 HUMERAL CUP 36/9.
Patient problems: Unspecified Infection
MAUDE report 13899863 ↗InjuryMar 23, 2022Device Dislodged or Dislocated
THE PATIENT WAS REVISED ON (B)(6) 2022 FOLLOWING THE PRIMARY SURGERY ON (B)(6) 2021 DUE TO DIS ASSOCIATION OF THE HUMERAL CUP. THE SURGEON EXPLANTED THE STANDARD HUMERAL CUP (36/9) AND IMPLANTED THE STABILITY HUMERAL CUP (36/9).
Patient problems: Joint Dislocation
MAUDE report 13863190 ↗InjuryMar 14, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 FOLLOWING PRIMARY SURGERY ON (B)(6) 2020 DUE TO INFECTION. THE PATIENT HAD AN INFECTION, AND THE SURGEON DID AN IRRIGATION AND DEBRIDEMENT, REPLACING THE HUMERAL CUP (36/9).
MAUDE report 13763165 ↗InjuryFeb 26, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
PATIENT REVISED ON (B)(6) 2021 DUE TO DISLOCATION APPROXIMATELY 6 MONTHS AFTER THE PRIMARY SURGERY . SURGEON EXPLANTED THE 135/145 36/+9 STANDARD HUMERAL CUP AND REPLACED IT WITH A 36/+9 STANDARD HUMERAL CUP AND 135/145 REVERSED ADAPTER FOR AN EXTRA +9MM OF SPACING.
Patient problems: Failure of Implant
MAUDE report 11383439 ↗
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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