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 2020-03-30 for CORAIL REVISION STEM STD 11 L98011 manufactured by Depuy France Sas - 3003895575.
[186782835]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[186782836]
According to the surgeon, the decision to revise was taken because the patient had pain and on the x-ray, the corail size 11 seemed to be loose. During the surgery, the cup was found to be well fixed and the corail standard stem size 11 was loose and it was removed and replaced with an corail revision size 15 (l98015) and a ceramic head size 36 +5 (136536320). .
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09568 |
| MDR Report Key | 9897782 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-30 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY FRANCE SAS 3003895575 |
| Manufacturer Street | 7 ALLEE IRENE JOLIOT-CURIE B.P. 256 |
| Manufacturer City | SAINT PRIEST CEDEX 69801 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORAIL REVISION STEM STD 11 |
| Generic Name | CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM |
| Product Code | LWJ |
| Date Received | 2020-03-30 |
| Model Number | L98011 |
| Catalog Number | L98011 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY FRANCE SAS - 3003895575 |
| Manufacturer Address | 7 ALLEE IRENE JOLIOT-CURIE B.P. 256 SAINT PRIEST CEDEX 69801 FR 69801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |