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 2019-11-21 for R3 20 DEG XLPE LNR 40MM ID X 64OD 71338691 manufactured by Smith & Nephew, Inc..
[167558509]
It was reported that revision surgery was performed for the third time. Aseptic loosening. Hip prepped and draped, jointly opened, specimens taken. Joint lavaged and debrided intensely. The femoral head removed, poly liner and cup and screws removed. Existing socket reamed to a bleeding bone bed. Implant trialed, joint lavaged again with hydrogen peroxide and more saline. Definitive acetabular implant inserted with bone cement. Tripolar liner/head trialed via reduction, hip stable, definitive tripolar implants inserted and hip reduced, hip closed. No more information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2019-04137 |
| MDR Report Key | 9360115 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-21 |
| Date of Report | 2019-11-21 |
| Date of Event | 2019-10-25 |
| Date Mfgr Received | 2019-10-25 |
| Date Added to Maude | 2019-11-21 |
| 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 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 20 DEG XLPE LNR 40MM ID X 64OD |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS |
| Product Code | MBL |
| Date Received | 2019-11-21 |
| Catalog Number | 71338691 |
| Lot Number | 10BM01100 |
| 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 | 2019-11-21 |