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 2019-12-17 for JOURNEY UNI TIBINRT S3-4LM/RL8MM 71422251 manufactured by Smith & Nephew, Inc..
[177355462]
It was reported that during surgery when implanting the insert, the insert could be easily placed in the tibial baseplate slot bare-handed (without the impactor). Also, testing with bent pliers, the insert could be easily taken out of the slot. Another insert of the same code was used, but the result was the same, and it was still left inside the patient. Since there was no revision instrument at that time and the surgeon could not guarantee the revision result, the suture wound treatment was selected at that time and the long-term postoperative situation of the patient was uncertain. There was a delay of 0-30 minutes reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2019-04417 |
| MDR Report Key | 9478623 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-17 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-11-21 |
| Date Mfgr Received | 2019-11-21 |
| Device Manufacturer Date | 2019-03-06 |
| Date Added to Maude | 2019-12-17 |
| 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 | JOURNEY UNI TIBINRT S3-4LM/RL8MM |
| Generic Name | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER |
| Product Code | HSX |
| Date Received | 2019-12-17 |
| Model Number | 71422251 |
| Catalog Number | 71422251 |
| Lot Number | 19CM04664 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2019-12-17 |