MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07 report with the FDA on 2009-11-02 for TC-PLUS manufactured by Aarau Switzerland Manufacturing Site.
[1326440]
It has been reported by another country's facility to smith & nephew that a revision surgery was performed due to instability. The revision occurred approximately 1-3 years after implantation. This is all of the info that has been received at this time.
Patient Sequence No: 1, Text Type: D, B5
[8365058]
Na
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613369-2009-00159 |
| MDR Report Key | 1520613 |
| Report Source | 00,01,07 |
| Date Received | 2009-11-02 |
| Date of Report | 2009-11-02 |
| Date Mfgr Received | 2009-10-02 |
| Date Added to Maude | 2009-11-06 |
| 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 Contact | MRS. LEAH EASLEY |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996137 |
| Manufacturer G1 | AARAU SWITZERLAND MANUFACTURING SITE |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5000 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 5000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TC-PLUS |
| Generic Name | FEMORAL/TIBIAL / KRP |
| Product Code | KRP |
| Date Received | 2009-11-02 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AARAU SWITZERLAND MANUFACTURING SITE |
| Manufacturer Address | AARAU SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-11-02 |