MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1998-12-09 for TIBIAL INSERT 1890-0420 manufactured by Wright Medical Technology, Inc..
[116820]
Revision surgery -- fractured post. Allegedly knee was not stable and required revision surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-1998-00113 |
| MDR Report Key | 201449 |
| Report Source | 05,07 |
| Date Received | 1998-12-09 |
| Date of Report | 1998-11-10 |
| Date of Event | 1998-11-02 |
| Date Mfgr Received | 1998-11-10 |
| Date Added to Maude | 1998-12-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TIBIAL INSERT |
| Generic Name | KNEE COMPONENT |
| Product Code | KRP |
| Date Received | 1998-12-09 |
| Returned To Mfg | 1998-11-11 |
| Model Number | NA |
| Catalog Number | 1890-0420 |
| Lot Number | M706210 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 195669 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 5677 AIRLINE RD. ARLINGTON TN 38002 US |
| Baseline Brand Name | ADVANTIM THICK POSTERIOR STABILIZED TIBIAL INSERT |
| Baseline Generic Name | KNEE COMPONENT |
| Baseline Catalog No | 1890-0420 |
| 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 | 1998-12-09 |