MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-26 for ZIMMER NATURAL HIP SYSTEM 7352-75-000 manufactured by Zimmer.
[18415436]
The first hip implant (b)(6) 2006, began to loosen after a few months, because the product used to hold the implant in place began to fall apart. Another surgery attempt was made on (b)(6) 2008, to replace the implant. At that point, there was such a bad infection, that they had to close the incision and began a pic-line to let it heal. Finally, on (b)(6) 2008, a second implant was completed. The incision continued to drain, and would not heal. On (b)(6) 2008, a fourth and final surgery was done to flush and place a drain. There was a delay in making any kind of report or inquiry of this due to the on going illness surgeries hospital stays and stress. And i had no one else to take care or any problems for me. My husband had just passed away a few weeks prior to my falling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019295 |
| MDR Report Key | 1981313 |
| Date Received | 2011-01-26 |
| Date of Report | 2011-01-21 |
| Date of Event | 2006-03-19 |
| Date Added to Maude | 2011-02-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER NATURAL HIP SYSTEM |
| Generic Name | HIP IMPLANT |
| Product Code | JDI |
| Date Received | 2011-01-26 |
| Model Number | NA |
| Catalog Number | 7352-75-000 |
| Lot Number | 1659371 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER |
| Brand Name | CENTERPULSE ORTHOPEDICS INC. |
| Generic Name | HIP IMPLANT |
| Product Code | JDI |
| Date Received | 2011-01-26 |
| Model Number | NA |
| Catalog Number | 7210-26-000 |
| Lot Number | 1643737 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | CENTERPULSE ORTHOPEDICS INC. |
| Brand Name | SULZER ORTHOPEDICS |
| Generic Name | HIP IMPLANT |
| Product Code | JDI |
| Date Received | 2011-01-26 |
| Model Number | NA |
| Catalog Number | 4404-26-042 |
| Lot Number | 1530368 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | SULZER ORTHOPEDICS |
| Brand Name | MICROTEK |
| Generic Name | CEMENT RESTRICTOR |
| Product Code | JDK |
| Date Received | 2011-01-26 |
| Model Number | NA |
| Catalog Number | 0180-125 |
| Lot Number | C6160 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK |
| Brand Name | SURGICAL SIMPLEX |
| Generic Name | RADIO PAQUE BONE CEMENT |
| Product Code | LOD |
| Date Received | 2011-01-26 |
| Model Number | NA |
| Catalog Number | 8191-1-001 |
| Lot Number | RDN109 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Manufacturer Address | MAHWAH NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2011-01-26 |