MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-13 for EVOLUTION(R) CS/CR FEMORAL HOLDER/DRIVER E100-5103 manufactured by Microport Orthopedics Inc..
[42555001]
This report will be updated when investigation is complete. Trends will be evaluated.
Patient Sequence No: 1, Text Type: N, H10
[42555002]
During the surgery the final pin of the instrument cracked (see pic).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010536692-2016-00466 |
| MDR Report Key | 5574123 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-13 |
| Date of Report | 2016-04-13 |
| Date of Event | 2016-04-01 |
| Date Facility Aware | 2016-04-08 |
| Date Mfgr Received | 2016-07-27 |
| Date Added to Maude | 2016-04-13 |
| 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 Street | 5677 AIRLINE ROAD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 9018674771 |
| Manufacturer G1 | MICROPORT ORTHOPEDICS INC. |
| Manufacturer Street | 5677 AIRLINE RD. |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVOLUTION(R) CS/CR FEMORAL HOLDER/DRIVER |
| Generic Name | KNEE INSTRUMENT |
| Product Code | HXK |
| Date Received | 2016-04-13 |
| Catalog Number | E100-5103 |
| Lot Number | 1354741 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROPORT ORTHOPEDICS INC. |
| Manufacturer Address | 5677 AIRLINE RD. ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-13 |