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 2020-03-09 for GII FEMORAL IMPACTOR 71440190 manufactured by Smith & Nephew, Inc..
[182563928]
It was reported that a piece of the impacting surface chipped off during impaction. The device broke inside of the patient. Surgery was completed with the same device. No backup device was available, but surgery was completed with the same device and a delay no greater than 30 min was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-00816 |
| MDR Report Key | 9805741 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-03-09 |
| 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 | GII FEMORAL IMPACTOR |
| Generic Name | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CMENTD, METAL/POLYMR |
| Product Code | HRY |
| Date Received | 2020-03-09 |
| Returned To Mfg | 2020-03-02 |
| Model Number | 71440190 |
| Catalog Number | 71440190 |
| Lot Number | 17DM09118 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-09 |