MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-14 for PHANTOM FIBER SUTURE manufactured by Tornier.
[49972823]
We used tornier phantom fiber in a number of our total knee replacement patients and noticed that the suture did not absorb after the 1 year that we were told, and they caused swelling and irritation of the knee. We have had to go remove the suture with an open procedure on about a dozen patients. Used on multiple patients in 2015. Dates of use: (b)(6) 2015. Diagnosis or reason for use: suture the fascia layer closed after tka. Event abated after use stopped or dose reduced: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063483 |
| MDR Report Key | 5802586 |
| Date Received | 2016-07-14 |
| Date of Report | 2016-07-14 |
| Date Added to Maude | 2016-07-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PHANTOM FIBER SUTURE |
| Generic Name | SUTURE |
| Product Code | NWJ |
| Date Received | 2016-07-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2016-07-14 |