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 2020-02-19 for JOURNEY UNI TIBINRT S5-6RM/LL11MM 71422268 manufactured by Smith & Nephew, Inc..
[181385091]
It was reported that a patient who had surgery on (b)(6) /2019, was rehabilitating well with minimal pain. However, when walking down a slope, the patient slipped and fell, having an immediate onset of knee pain and catching. The x-rays revealed poly had flipped out of the tibial tray. Revision surgery was performed and during the procedure, femoral and tibial components were well fixed. Poly was loose and not sitting in the tibial tray as expected and explanted. The surgeon also elected to explant the tibial tray, recut the tibial with more slope to improve flexion space and loading. He re-implanted the same size tibial tray and inserted a size 11 poly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-00635 |
| MDR Report Key | 9728096 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2012-04-09 |
| Date Added to Maude | 2020-02-19 |
| 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 | JOURNEY UNI TIBINRT S5-6RM/LL11MM |
| Generic Name | PROST, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLY |
| Product Code | HSX |
| Date Received | 2020-02-19 |
| Model Number | 71422268 |
| Catalog Number | 71422268 |
| Lot Number | 12DM04452 |
| 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 | 2020-02-19 |