MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-12-23 for BIOACTION UNK manufactured by Osteomed L.p..
[981096]
In a recent conversation the surgeon stated that he had experienced two cases in 2005 or 2006 where the polypropylene insert had separated from the metal bioaction implant approximately 3-4 months post operatively. The parts were explanted, discarded, and replaced with new implants. Patients recovered uneventfully. This happened sometime in 2005 or 2006. Company was not notified at that time. Doctor was not sure if patient was compliant with regards to footwear in the postop period. Seven additional requests for information or details have gone unanswered. No lot number or part number information was given. This report is based solely on doctor's representation that these were bioaction implants. There is not data to confirm or deny the representation. Review of field experience history for this product family does not reveal similar postoperative complaints - this is the only such report. Separation could be cause by intraoperative damage such as grabbing with an instrument. Depending on degree of damage it may have facilitated tissue ingrowth, further separating the polypropylene insert from the metal implant. Without additional information, no conclusion can be drawn.
Patient Sequence No: 1, Text Type: D, B5
[8167457]
Doctor was not sure if patient was complaint with regards to footwear in the postop period. Doctor promised to provide additional information however 7 additional requests for information or details have gone unanswered. No lot number or part number information was given. This report is based solely on doctor's representation that these were bioaction implants. There is no data to confirm or deny the representation. Review of field experience history for this product family does not reveal similar postoperative complaint - this is the only such report. Separation could be caused by intraoperative damage such as grabbing with an instrument. Depending on degree of damage it may have facilitated tissue ingrowth, further separating the polypropylene insert from the metal implant. Without additional information, no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027754-2008-00016 |
| MDR Report Key | 1274998 |
| Report Source | 05,07 |
| Date Received | 2008-12-23 |
| Date of Report | 2008-12-18 |
| Date of Event | 2005-01-01 |
| Date Mfgr Received | 2008-11-19 |
| Date Added to Maude | 2009-01-07 |
| 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 |
| Generic Name | MPJ IMPLANT |
| Product Code | LZJ |
| Date Received | 2008-12-23 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOMED L.P. |
| Manufacturer Address | ADDISON TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-12-23 |