MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-11-02 for 3S HEMI IMPLANT, MEDIUM, NON-STERILE 101-00-002 manufactured by Trilliant Surgical.
[126068379]
It was reported by a sales representative that the patient who was implanted with a 101-00-002 (3s hemi medium implant) revisited the surgeon for a check-up approximately 3 years post surgery due to pain at the surgical site. Post-assessment of x-rays taken, the surgeon confirmed a shift of the implant on the plantar aspect wherein resulted in a significant shortening of the hallux. At the time of the visit, the surgeon believed further shifting may occur and that removal is necessary to alleviate further shifting/shortening of the hallux. Dhr review was not conducted on the 3s hemi medium implant, 101-00-002, as the lot number is unknown. A review of the x-rays provided x-rays upon initial implantation and the re-visit were completed. X-rays were received of initial implantation and at the visit (b)(6) 2018. After review, it was noted that the implant was not seated flush with the bone as specified in labeling. The hallux was also noted to be lifting up. Bone resorption may also have occurred as the proximal phalanx appears shorter in length than in initial x-rays. The x-rays during the re-visit confirmed the implant has shifted on the plantar aspect. The surgeon plans to remove the implant. No known surgery has occurred to-date. If additional details that would impact the conclusion of this report are reported to trilliant surgical, a supplemental report shall be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420745-2018-00016 |
| MDR Report Key | 8035495 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-11-02 |
| Date of Report | 2018-11-02 |
| Date of Event | 2018-09-17 |
| Date Mfgr Received | 2018-10-05 |
| Date Added to Maude | 2018-11-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JODIE RODRIGUEZ |
| Manufacturer Street | 727 N. SHEPHERD DR. SUITE 100 |
| Manufacturer City | HOUSTON TX 77007 |
| Manufacturer Country | US |
| Manufacturer Postal | 77007 |
| Manufacturer Phone | 8004952919 |
| Manufacturer G1 | TRILLIANT SURGICAL |
| Manufacturer Street | 727 N. SHEPHERD DR. SUITE 100 |
| Manufacturer City | HOUSTON TX 77007 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77007 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3S HEMI IMPLANT, MEDIUM, NON-STERILE |
| Generic Name | 3S HEMI IMPLANT, MEDIUM, NON-STERILE |
| Product Code | KWD |
| Date Received | 2018-11-02 |
| Model Number | 101-00-002 |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRILLIANT SURGICAL |
| Manufacturer Address | 727 N. SHEPHERD DR. SUITE 100 HOUSTON TX 77007 US 77007 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-02 |