MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study,use report with the FDA on 2019-12-04 for R3 0 DEG XLPE ACET LNR 36MM X 52MM 71332752 manufactured by Smith & Nephew, Inc..
[169196682]
It was reported that the patient was hospitalized due to a bilateral pulmonary embolism. The event was treated with medication therapy and the patient was discharged the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2019-04287 |
| MDR Report Key | 9413701 |
| Report Source | HEALTH PROFESSIONAL,STUDY,USE |
| Date Received | 2019-12-04 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-10-07 |
| Date Mfgr Received | 2019-11-07 |
| Device Manufacturer Date | 2019-05-09 |
| Date Added to Maude | 2019-12-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 Phone | 0447940038 |
| 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 | R3 0 DEG XLPE ACET LNR 36MM X 52MM |
| Generic Name | PROSTHESIS, HIP, SEMI-CONS, UNCEMENTED, METAL/POLY, POROUS |
| Product Code | MBL |
| Date Received | 2019-12-04 |
| Model Number | 71332752 |
| Catalog Number | 71332752 |
| Lot Number | 19EM08255 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-12-04 |