MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-30 for CORAIL2 LAT COXA VARA SIZE 12 3L93712 manufactured by Depuy France Sas - 3003895575.
[186276235]
Product complaint # (b)(4). Initial reporter occupation: lawyer. (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
[186276236]
Litigation alleges that patient experienced pain, weakness, difficulty with simple daily living activities, inability to return to work, and increased metallic ions in his bloodstream. Revision operative note reviewed and confirmed metallosis. The revision operative note also mentions alval. In addition to what previously alleged, litigation alleged metal wear, skin rashes, weight loss, pain, increase incidence of atrial fibrillation, anxiety, thirst, loose of taste, metallic taste in saliva, and dry fragile skin. After review of medical records it was indicated that the patient present with progressive worsening left hip pain, demonstrated elevated metal ions. The patient was then revised for painful metal-sensitivity reaction to necrosis (alval). Operative notes reported that the cup was little generously anteverted and there was some erosive deficiency noted of the anterior acetabular bony wall, due to inflammatory process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09613 |
| MDR Report Key | 9899654 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2012-05-23 |
| Date of Event | 2011-03-16 |
| Date Mfgr Received | 2020-03-15 |
| Device Manufacturer Date | 2008-10-31 |
| 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 |
| 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. B.P. 256 |
| Manufacturer City | WARSAW 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| 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 | CORAIL2 LAT COXA VARA SIZE 12 |
| Generic Name | CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM |
| Product Code | KWA |
| Date Received | 2020-03-30 |
| Model Number | 3L93712 |
| Catalog Number | 3L93712 |
| Lot Number | 2743913 |
| Device Expiration Date | 2013-09-01 |
| 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 |