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 |