MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-01-24 for CEMENTRALIZER 12.0 137621000 manufactured by Depuy Orthopaedics Inc Us.
[133942373]
(b)(4). Reporter is an attorney.
Patient Sequence No: 1, Text Type: N, H10
[133942374]
Litigation alleges that the patient suffers from pain, swelling, infection, and fracture. Update ad 06 jun 2018: receipt of ppf and sticker sheets. In addition to what was previously alleged, ppf alleges dislocation. Patient is deceased however there is no information provided about the reason and date of death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-82059 |
| MDR Report Key | 8273282 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2019-01-24 |
| Date of Report | 2019-01-04 |
| Date of Event | 2009-06-08 |
| Date Mfgr Received | 2019-10-28 |
| Device Manufacturer Date | 2008-12-29 |
| Date Added to Maude | 2019-01-24 |
| 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 | 6103142063 |
| 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 MISCELLANEOUS : CEMENT CENTRALIZER/PLUG |
| Product Code | LTO |
| Date Received | 2019-01-24 |
| Catalog Number | 137621000 |
| Lot Number | C97FP1000 |
| 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 | 2019-01-24 |