MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for ACCORD 71340013 manufactured by Smith & Nephew, Inc..
[183517187]
This is a male patient who underwent right total hip arthroplasty. Patient was doing well post-operatively. Went to md office for follow up visit and x-ray reveals a fracture in the plate. 2 weeks later, patient to operating room for removal of broken plate, insertion of new synthes plate and cerclage and allograft strut.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9834981 |
| MDR Report Key | 9834981 |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-11-06 |
| Report Date | 2020-03-04 |
| Date Reported to FDA | 2020-03-04 |
| Date Reported to Mfgr | 2020-03-16 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCORD |
| Generic Name | CERCLAGE, FIXATION |
| Product Code | JDQ |
| Date Received | 2020-03-16 |
| Model Number | 71340013 |
| Catalog Number | 71340013 |
| Lot Number | 18GSM0670 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 7135 GOODLETT FARMS PKWY CORDOVA TN 38016 US 38016 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-16 |