MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-17 for JOURNEY FEM IMPACT BUMPER LT 74012821 manufactured by Smith & Nephew, Inc..
[177239481]
It was reported that during surgery, the femoral bumper was attached to femoral implant impactor and after impaction of the implant the bumper was taken off of the impactor and the bumper was broken. All pieces were found, nothing was dropped into the wound. No delay and no injury reported. Procedure was concluded with same device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-00316 |
| MDR Report Key | 9603401 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-17 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2015-01-13 |
| Date Added to Maude | 2020-01-17 |
| 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 |
| 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 FEM IMPACT BUMPER LT |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Product Code | MDM |
| Date Received | 2020-01-17 |
| Model Number | 74012821 |
| Catalog Number | 74012821 |
| Lot Number | 15AM08083 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| 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 | 2020-01-17 |