MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-05-25 for FEM RASP TRIAL CO/FJD T8 L93208 manufactured by Depuy France Sas - 3003895575.
[109504728]
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
[109504729]
Two proud corail implants yesterday due to rasp implant mismatch. At this time it's unknown what size of broach/rasp were used during these cases. All are being reported at this time on linked pcs. The two stem are reported two stems are reported in two separate linked pcs. Doe: (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
[131725299]
Product complaint # : (b)(4). The device was returned, and the failure mode was confirmed depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[131727116]
Product complaint # : (b)(4). The device was returned, and the failure mode was confirmed. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. 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
| Report Number | 1818910-2018-60477 |
| MDR Report Key | 7544094 |
| Report Source | OTHER |
| Date Received | 2018-05-25 |
| Date of Report | 2018-04-26 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-12-18 |
| Device Manufacturer Date | 2014-04-09 |
| Date Added to Maude | 2018-05-25 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DR. BP 256 |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FEM RASP TRIAL CO/FJD T8 |
| Generic Name | OTHER PRODUCTS |
| Product Code | HTR |
| Date Received | 2018-05-25 |
| Returned To Mfg | 2018-05-24 |
| Catalog Number | L93208 |
| Lot Number | 5220070 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-25 |