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 2017-09-19 for CEMENTRALIZER 12.0 137621000 manufactured by Depuy Orthopaedics, Inc.1818910.
[86617180]
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
[86617181]
It was reported that after implanting the revision products, the patient was closed up and began experiencing problems. The patient died in room. The surgeon later stated that it was probably due to fat embolism. Competitor cement was reported to be used during the revision.
Patient Sequence No: 1, Text Type: D, B5
[95541251]
No device associated with this report was received for examination. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. 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
| Report Number | 1818910-2017-24928 |
| MDR Report Key | 6876365 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-19 |
| Date of Report | 2017-08-20 |
| Date of Event | 2017-08-20 |
| Date Mfgr Received | 2017-10-18 |
| Device Manufacturer Date | 2015-09-28 |
| Date Added to Maude | 2017-09-19 |
| 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 | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC.1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEMENTRALIZER 12.0 |
| Generic Name | HIP FEMORAL HEAD |
| Product Code | LTO |
| Date Received | 2017-09-19 |
| Catalog Number | 137621000 |
| Lot Number | 697774 |
| 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.1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-09-19 |