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 STD SIZE 11 3L92511 manufactured by Depuy France Sas - 3003895575.
[186700858]
(b)(4). Initial reporter occupation: lawyer. 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
[186700859]
It was reported that patient had hip pain, elevated cobalt chrome levels and metallosis. Patient alleges atrial fibrillation, hypothyroidism, sleep apnea, edema, insomnia, and pain after review of the medical records, the patient was revised to address painful left total hip replacement secondary to metallosis. Revision operative note reported that the trunnion demonstrated evidence of metallosis with dark staining.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09601 |
| MDR Report Key | 9898777 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2019-06-25 |
| Date of Event | 2019-06-25 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2010-02-17 |
| 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 ORTHOPEDICS DRIVE |
| 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 | CORAIL2 STD SIZE 11 |
| Generic Name | CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM |
| Product Code | KWA |
| Date Received | 2020-03-30 |
| Model Number | 3L92511 |
| Catalog Number | 3L92511 |
| Lot Number | 5025160 |
| Device Expiration Date | 2015-01-31 |
| 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 |