MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2020-01-31 for R3 0 DEG XLPE ACET LNR 40MM X 64MM 71338683 manufactured by Smith & Nephew, Inc..
[177161904]
It was reported that the patient underwent two closed reductions due to recurrent dislocations. The first closed reduction was performed on (b)(6) 2018 and the second one on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-00427 |
| MDR Report Key | 9653097 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date of Event | 2018-07-03 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2010-01-30 |
| Date Added to Maude | 2020-01-31 |
| 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 40MM X 64MM |
| Generic Name | PROSTH, HIP, SEMI-CONS, UNCEMENTED, METAL/POLYMER, POROUS |
| Product Code | MBL |
| Date Received | 2020-01-31 |
| Model Number | 71338683 |
| Catalog Number | 71338683 |
| Lot Number | 10AM02372 |
| Device Expiration Date | 2020-01-28 |
| 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 | 2020-01-31 |