MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2005-01-24 for DURAMER ADVANTIM POST. STAB. TIBIAL INSERT 1890-1212 manufactured by Wright Medical Technology, Inc..
[347744]
Allegedly loosening.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2005-00009 |
| MDR Report Key | 568027 |
| Report Source | 01,07 |
| Date Received | 2005-01-24 |
| Date of Report | 2005-01-21 |
| Date of Event | 2004-04-19 |
| Date Mfgr Received | 2004-04-19 |
| Date Added to Maude | 2005-01-28 |
| 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 | DEBBY DAURER |
| Manufacturer Street | 5677 AIRLINE ROAD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 9018674601 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 5677 AIRLINE ROAD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURAMER ADVANTIM POST. STAB. TIBIAL INSERT |
| Generic Name | KNEE COMPONENT |
| Product Code | KRP |
| Date Received | 2005-01-24 |
| Returned To Mfg | 2004-05-05 |
| Model Number | NA |
| Catalog Number | 1890-1212 |
| Lot Number | 26443 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | R |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 557855 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | * ARLINGTON TN * US |
| Baseline Brand Name | DURAMER ADVANTIM POST STABILIZED TIBIAL INSERT |
| Baseline Generic Name | KNEE COMPONENT |
| Baseline Catalog No | 1890-1212 |
| Baseline Device Family | K J 888.3560 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-01-24 |