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 2020-03-30 for C-STEM AMT SZ1 HI OFFSET 1570-14-070 157014070 manufactured by Depuy International Ltd - 8010379.
[186723455]
(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
[186723456]
The patient was revised to address femoral component revision due to preprosthetic fracture sustained during a fall. Cstem femur was removed and replaced with a reclaim revision stem construct and luque wires. Doi: (b)(6) 2019. Dor: (b)(6) ) 2020. Affected side: left hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09598 |
| MDR Report Key | 9898371 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2018-01-05 |
| 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 |
| 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 DR. |
| 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 | C-STEM AMT SZ1 HI OFFSET |
| Generic Name | C-STEM HIP IMPLANT : HIP FEMORAL STEM |
| Product Code | JDI |
| Date Received | 2020-03-30 |
| Model Number | 1570-14-070 |
| Catalog Number | 157014070 |
| Lot Number | D17122468 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY INTERNATIONAL LTD - 8010379 |
| Manufacturer Address | ST. ANTHONY'S ROAD LEEDS LS118DT UK LS11 8DT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |