MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-25 for PROFIX {} C/R HA POR FEM SZ 5 LT 71503250 manufactured by Smith & Nephew, Inc..
[185932983]
It was reported that the patient underwent revision total knee replacement surgery for an unstable knee and continuing increase of pain over a number of years. The original knee surgery was performed in (b)(6) 2005. It was reported that the femur had loosened and that the bone quality was quite poor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-01017 |
| MDR Report Key | 9881262 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2004-11-07 |
| Date Added to Maude | 2020-03-25 |
| 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 | DR. SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROFIX {} C/R HA POR FEM SZ 5 LT |
| Generic Name | PRSTHSS,KNEE,PATELLO/FMOROTBIAL,SMI-CNSTRND,UNCMNTD,POROUS,COTED,PLYMR/MTL/PLYMR |
| Product Code | MBH |
| Date Received | 2020-03-25 |
| Model Number | 71503250 |
| Catalog Number | 71503250 |
| Lot Number | 04GM17371B |
| Device Expiration Date | 2014-09-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-25 |