MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-11-18 for CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY 9070-0013-W / 9122-2030-W manufactured by Arthrosurface.
[31547624]
The device was explanted by another surgeon and was not returned for evaluation by the manufacturer. It was learned that the patient had an unrelated condition known as tarsel tunnel syndrome, which is an impringment disorder of the tibial nerve in the ankle, which creates radiating pain symptoms throughout the foot. Following revision surgery, it was found that patient had resumed routine daily activities.
Patient Sequence No: 1, Text Type: N, H10
[31547685]
Patient reported pain and was unsatisfied with the outcome of the procedure. The patient also decided to undergo a revision surgery in which the implant components were explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2013-00003 |
| MDR Report Key | 5233929 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-11-18 |
| Date of Report | 2015-10-26 |
| Date of Event | 2013-03-12 |
| Date Mfgr Received | 2013-03-13 |
| Date Added to Maude | 2015-11-18 |
| 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 | MR. PHANI PUPPALA |
| Manufacturer Street | 28 FORGE PARKWAY |
| Manufacturer City | FRANKLIN MA 02038 |
| Manufacturer Country | US |
| Manufacturer Postal | 02038 |
| Manufacturer Phone | 5085203003 |
| Manufacturer G1 | ARTHROSURFACE |
| Manufacturer Street | 28 FORGE PARKWAY |
| Manufacturer City | FRANKLIN MA 02038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY |
| Generic Name | HEMICAP - PROSTHESIS, TOE, HEMI-, PHALANGEAL |
| Product Code | KWD |
| Date Received | 2015-11-18 |
| Model Number | 9070-0013-W / 9122-2030-W |
| Catalog Number | 9070-0013-W / 9122-2030-W |
| Lot Number | L75BI0513 / 75AG2308 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROSURFACE |
| Manufacturer Address | 28 FORGE PARKWAY FRANKLIN MA 02038 US 02038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-18 |