MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03 report with the FDA on 2010-03-03 for BIOACTION FIRST MPJ UNK manufactured by Osteomed Lp.
[1435238]
Article published in foot and ankle surgery, (b)(6) 2010, pgs 25 - 27 talks about the survivorship of the bioaction mpj arthroplasty for hallux rigidus, 5 yr f/u. Study includes 14 pts treated by the same doctor. Based on the 5 yr f/u, the implants showed radiographic signs of loosening and in two pts implant removal and arthrodesis was performed for increasing toe pain at 61 and 63 months respectively. The study states the implants were placed using a medial approach and that no bone cement was used. The ifu clearly states that the approach should be dorsal, and that the implants are for cemented use only.
Patient Sequence No: 1, Text Type: D, B5
[8487731]
Doctor failed to use product in accordance with ifu. Doctor did not use bone cement and used different approach than recommended. Implant is for cemented use only. Implants not returned to company. No medical files available. This is info extracted from a published journal article.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027754-2010-00003 |
| MDR Report Key | 1625982 |
| Report Source | 01,03 |
| Date Received | 2010-03-03 |
| Date of Report | 2010-02-26 |
| Date Mfgr Received | 2010-02-17 |
| Date Added to Maude | 2011-12-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 3885 ARAPAHO RD. |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal | 75001 |
| Manufacturer Phone | 9726774787 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOACTION FIRST MPJ |
| Generic Name | GREAT TOE IMPLANT |
| Product Code | LZJ |
| Date Received | 2010-03-03 |
| Returned To Mfg | 2010-01-15 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOMED LP |
| Manufacturer Address | ADDISON TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-03-03 |