MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-24 for CORAIL REVISION STEM STD 11 L98011 manufactured by Depuy France Sas - 3003895575.
[184780229]
Product complaint #: (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
[184780230]
The surgeon sent me the x-rays of a hip replacement that he needs to review because the patient is in great pain. Then he called me to fix the date of the revision and then he asked me if i noticed that the stem was fractured in 2 places. There has been no surgical intervention and/or invasive treatment performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09060 |
| MDR Report Key | 9872450 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-24 |
| 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 | 2020-03-24 |
| Model Number | L98011 |
| Catalog Number | L98011 |
| Lot Number | NA |
| 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 | 2020-03-24 |