MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-08-18 for PHANTOM FIBER BIOFIBER SUTURE manufactured by Tornier Inc..
[52399802]
This is the final report submitted regarding this surgical event and medical device. Report cover-letter states that: "the report contains all the information presently available. " conducting follow up inquiry was impossible. Medwatch submitted: mw5063483.
Patient Sequence No: 1, Text Type: N, H10
[52399803]
Report received stated in the event description: "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" no further patient complications have been reported for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004983210-2016-00025 |
| MDR Report Key | 5885438 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-08-18 |
| Date of Report | 2016-07-28 |
| Date Mfgr Received | 2016-07-28 |
| Date Added to Maude | 2016-08-18 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DUSTIN SMITH |
| Manufacturer Street | 10801 NESBIT AVE SOUTH |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal | 55437 |
| Manufacturer Phone | 9529217121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHANTOM FIBER BIOFIBER SUTURE |
| Generic Name | SUTURE, RECOMBINANT TECHNOLOGY |
| Product Code | NWJ |
| Date Received | 2016-08-18 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER INC. |
| Manufacturer Address | 10801 NESBIT AVENUE SOUTH BLOOMINGTON MN 55437 US 55437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-18 |