MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-01-21 for R3 20 DEG XLPE ACET LNR 36MM X 60MM 71335760 manufactured by Smith & Nephew, Inc..
[175680912]
It was reported a subsequent right hip revision surgery due to septic hip. Liner and femoral head exchanged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-00351 |
| MDR Report Key | 9610966 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-21 |
| Date of Event | 2017-07-13 |
| Date Mfgr Received | 2019-11-05 |
| Device Manufacturer Date | 2013-01-24 |
| Date Added to Maude | 2020-01-21 |
| 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 | R3 20 DEG XLPE ACET LNR 36MM X 60MM |
| Generic Name | PROSTHESIS,HIP,SEMICONSTRAINED,METALPOLYMER,POROUS |
| Product Code | MBL |
| Date Received | 2020-01-21 |
| Model Number | 71335760 |
| Catalog Number | 71335760 |
| Lot Number | 13AM13298 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2020-01-21 |