MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-10-05 for ARTHROSURFACE TOEMOTION manufactured by Arthrosurface, Inc..
[56537324]
There is limited information regarding the patient's history with arthrosurface implants. The patient is currently looking for second opinion referrals and has been redirected to an arthrosurface rm in her area. Any additional information relevant to the patient issues received will be submitted through supplemental mdr's.
Patient Sequence No: 1, Text Type: N, H10
[56537325]
Patient reached out to arthrosurface via website and complains of restricted movement and tissue damage due to arthrosurface toe implant. The dates of initial and revision surgeries are unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2016-00013 |
| MDR Report Key | 6000792 |
| Report Source | CONSUMER |
| Date Received | 2016-10-05 |
| Date of Report | 2016-09-18 |
| Date Mfgr Received | 2016-09-18 |
| Date Added to Maude | 2016-10-05 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 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 | ARTHROSURFACE TOEMOTION |
| Generic Name | ARTHROSURFACE? TOTAL TOE - PROXIMAL PHALANX IMPLANT |
| Product Code | LZJ |
| Date Received | 2016-10-05 |
| Operator | PHYSICIAN |
| Device Availability | * |
| 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 | 2016-10-05 |