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 SUMMIT DUOFIX TAP SZ6 HI OFF 1570-12-120 157012120 manufactured by Depuy Orthopaedics Inc Us.
[186772844]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Initial reporter occupation: lawyer.
Patient Sequence No: 1, Text Type: N, H10
[186772845]
Pinnacle claim submission form and medical record received. After review of medical record the patient was revised to address left periprosthetic femur fracture. The surgeon opted to proceed with open reduction internal fixation left femur fracture and revision of femoral component. On patient's history of illness, she was experiencing pain, discomfort, subtle shortening of the limb and felt a pop in the hip. X-rays at an outside emergency department revealed a left periprosthetic femur fracture with clearly subsidence of the component. Revision note reported a series of cerclage wires were utilized to stabilized the reduction and excellent reduction was achieved. Doi: (b)(6) 2016; dor: (b)(6) 2016 (left hip).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09604 |
| MDR Report Key | 9899166 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-13 |
| Date of Event | 2016-10-20 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2016-01-27 |
| 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 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | JTE WARSAW MFG SITE |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465820988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUMMIT DUOFIX TAP SZ6 HI OFF |
| Generic Name | SUMMIT HIP STEM : HIP FEMORAL STEM |
| Product Code | LPH |
| Date Received | 2020-03-30 |
| Model Number | 1570-12-120 |
| Catalog Number | 157012120 |
| Lot Number | 731472 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-30 |