3S Hemi 101-00-002Recalls & reported problems
Trilliant Surgical, LLC · 3S Hemi Implant, Medium, Non-Sterile · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812926020082), received between Nov 2, 2018 and Nov 2, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (1 report).
1 other recall cover devices cleared under the same FDA submission (K072922); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Migration1
Patient problems
- Arthralgia1
- Impaired Healing1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration
AT FACILITY X ON (B)(6) 2018, A TRILLIANT SALES REPRESENTATIVE WAS NOTIFIED OF A 3S HEMI IMPLANT, MEDIUM, NON-STERILE (101-00-002) THAT CAUSED A 71-YEAR OLD-FEMALE PATIENT PAIN. IT WAS NOTED THAT THERE WAS NOTICEABLE ANGULATION. THE ORIGINAL IMPLANTATION OF THIS 3S HEMI IMPLANT, MEDIUM, NON-STERILE (101-00-002) WAS ON (B)(6) 2015. THE PATIENT CAME IN ON (B)(6) 2018 FOR FURTHER REVIEW OF THE PAIN AT THE SURGICAL SITE. UPON DOCTOR 1'S ASSESSMENT OF THE X-RAYS, HE NOTED THAT THE IMPLANT HAD SHIFTED ON THE PLANTAR ASPECT. ACCORDING TO DOCTOR 1, THIS SHIFT CORRELATED WITH THE SIGNIFICANT SHORTENING OF THE HALLUX. DOCTOR 1 BELIEVED THAT THE IMPLANT MAY STILL SHIFT AND HE CONCLUDED A COMPLETE REMOVAL WILL BE NECESSARY WITHIN THE NEXT FEW WEEKS.
Patient problems: Arthralgia; Impaired Healing
MAUDE report 8035495 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K072922. One submission often covers many models, so check the product and lot details in each record.
- Z-1611-2020 · Jul 19, 2018 · TerminatedInstructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe Implant System, Model 111-00-001. The firm name on the label is Trilli
Other Prosthesis, Toe, Hemi-, Phalangeal devices
- TOE JOINT TITANIUM NPC MD 20MM 16814Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM NPC LG 23MM 16816Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM NPC SM 17MM 16813Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM PC M/S 18.5MM 17197Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM PC SM 17MM 17035Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM PC MD 20MM 17036Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM NPC M/L 21.5MM 16815Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- BioPoly® Great Toe Hemiarthroplasty Implant 135-5118Biopoly, LLC · Prosthesis, Toe, Hemi-, Phalangeal3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.