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 2020-03-18 for PINN CAN BONE SCREW 6.5MMX25MM 1217-25-500 121725500 manufactured by Depuy Orthopaedics Inc Us.
[184076434]
(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
[184076435]
Clinical adverse event received for hematogenous seeding of his right hip: infection - deep; had a gangrenous gallbladder which seeded his hip. Event is serious and is considered moderate. Event is definitely related to device and is definitely not related to procedure. Date of implantation: (b)(6) 2020; date of event (onset): (b)(6) 2020; (right hip). Treatment: surgical irrigation & debridement, without revision of head and liner; medication: oral ancef 1 gm tid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-08434 |
| MDR Report Key | 9847957 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2019-09-05 |
| Date Added to Maude | 2020-03-18 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | JJMSZ PLANT FOR STK. & N-STK. |
| Manufacturer Street | NO. 299, CHANGYANG STREET SUZHOU INDUSTRIAL PARK |
| Manufacturer City | SUZHOU, JIANGSU 215126 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215126 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINN CAN BONE SCREW 6.5MMX25MM |
| Generic Name | BONE SCREWS AND PINS : SCREWS |
| Product Code | NDJ |
| Date Received | 2020-03-18 |
| Model Number | 1217-25-500 |
| Catalog Number | 121725500 |
| Lot Number | D19043304 |
| 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 ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-18 |