MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-05 for POLYFLEX SYSTEM PLASTIC LIGAMENT-30MM (SHORT) 12-1105 manufactured by Smith And Nephew, Inc..
[118261]
Pt had a cruciate ligament implanted in his knee in 11/76. The ligament did not function properly so it was taken out of his knee in 6/94. He was also concerned that the polymethyl methacrylate used, as indicated in the instructions for use, was not medical grade. Smith & nephew confirmed the mfg site. Rep didn't believe this catalog number/device was still being mfg by the firm. The complainant was asked to send medical records to send with the complaint. To date the complainant hasn't sent the medical records. The complaint will be forwarded to another department for proper action.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002343 |
| MDR Report Key | 190694 |
| Date Received | 1998-10-05 |
| Date of Report | 1998-08-07 |
| Date of Event | 1994-06-01 |
| Date Added to Maude | 1998-10-08 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYFLEX SYSTEM |
| Generic Name | PLASTIC CRUCIATE LIGAMENT |
| Product Code | LML |
| Date Received | 1998-10-05 |
| Model Number | PLASTIC LIGAMENT-30MM (SHORT) |
| Catalog Number | 12-1105 |
| Lot Number | NI |
| ID Number | CERT 316 IG4020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 185299 |
| Manufacturer | SMITH AND NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-10-05 |