MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-12 for BROACH CORAIL AMT 13 L20313 L20413 manufactured by Depuy France Sas - 3003895575.
[188529494]
(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
[188529495]
Clinical adverse event received for small calcar fracture: periprosthetic bone. Fracture femoral (intraoperative during primary). Event is serious and is considered mild. Event is possibly related to both device and procedure. Date of implantation: (b)(6) 2020. Date of event (onset): (b)(6) 2020; (left hip). Treatment: open reduction internal fixation left hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-07668 |
| MDR Report Key | 9825526 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-05-01 |
| Date Added to Maude | 2020-03-12 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC 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 | BROACH CORAIL AMT 13 |
| Generic Name | HIP INSTRUMENTS : BROACHES |
| Product Code | HTQ |
| Date Received | 2020-03-12 |
| Model Number | L20313 |
| Catalog Number | L20413 |
| Lot Number | 5343493 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-12 |