MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-05-24 for CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT manufactured by Arthrosurface, Inc..
[75871098]
The patient has been advised to contact the regulatory department if she believes there are deficiencies concerning quality, safety, durability, reliability, effectiveness or performance of the device. No response has been received as of the reported date. However, based on the information provided by the patient, the pain could be related to pre-existing conditions such as scar tissue and plantar fascitis and/or other related factors. There are many factors such as patient selection criteria, operating technique, compliance to post-op rehabilitation technique etc, that contribute to the successful outcome of the surgery. There is no clinical evidence indicating the failure of arthrosurface implant or its contribution to the reported issues. The lot number of the device was not provided, without which the dhr or performance history review is not possible. The patient is currently pursuing further treatment with alternative options from her current surgeon. The complaint is considered closed. Should arthrosurface receive additional information regarding this complaint, a supplemental mdr will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[75871099]
Patient reached out to arthrosurface via website and expressed dissatisfaction over arthrosurface implant as her treating physician is going to fuse her joint. The patient stated she has a toe hemicap implanted 2 years ago and since, has not received adequate pain relief. Following implantation of hemicap, she underwent 2 additional surgeries to remove scar tissue which did not help with pain relief. The patient also stated that she has plantar fascitis (in both feet) which is causing additional pain in her arches and ankles. She also developed a baker's cyst from uneven walking. Patient is concerned that she cannot wear stilettos or shoes due to a big lump on the side of her toe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2017-00006 |
| MDR Report Key | 6588080 |
| Report Source | CONSUMER |
| Date Received | 2017-05-24 |
| Date of Report | 2017-05-05 |
| Date Mfgr Received | 2017-05-05 |
| Date Added to Maude | 2017-05-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PHANI PUPPALA |
| Manufacturer Street | 28 FORGE PARKWAY |
| Manufacturer City | FRANKLIN MA 02038 |
| Manufacturer Country | US |
| Manufacturer Postal | 02038 |
| Manufacturer Phone | 5085203003 |
| Manufacturer G1 | PRIMO MEDICAL GROUP |
| Manufacturer Street | 75 MILL ST. |
| Manufacturer City | STOUGHTON MA 02072 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02072 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT |
| Generic Name | TOE JOINT PHALANGEAL (HEMI-TOE) POLYMER PROSTHESIS |
| Product Code | KWD |
| Date Received | 2017-05-24 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROSURFACE, INC. |
| Manufacturer Address | 28 FORGE PARKWAY FRANKLIN MA 02038 US 02038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-24 |