MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-27 for ARTHROSURFACE TOEMOTION manufactured by Arthrosurface, Inc..
[101119278]
The reason for reported pain and limited range of motion (rom) could not be determined due to limited information received. The part and lot information of the devices in question is unknown. Hence, a review of the dhrs (device history records) could not be conducted. The package insert states that this type of event(s) can occur and all risks are addressed in the risk documentation. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. The patient was revised to a different implant from another manufacturer and arthrosurface toemotion components have been explanted. Should arthrosurface receive any additional information which would change or alter any conclusions or information, a supplemental mdr will be filed accordingly. We will continue to monitor the trends.
Patient Sequence No: 1, Text Type: N, H10
[101119279]
A revision notification was received which stated that a toemotion patient was revised due to pain and limited range of motion (rom).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2018-00003 |
| MDR Report Key | 7301316 |
| Date Received | 2018-02-27 |
| Date of Report | 2018-01-27 |
| Date Added to Maude | 2018-02-27 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 0 |
| Brand Name | ARTHROSURFACE TOEMOTION |
| Generic Name | ARTHROSURFACE? TOTAL TOE - PROXIMAL PHALANX IMPLANT |
| Product Code | LZJ |
| Date Received | 2018-02-27 |
| 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 | 2018-02-27 |