MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-08 for ADVANTIM TOTAL KNEE FEMUR,TIBIAL,INSERT 18950014,18550300,18903314 manufactured by Wright Medical Technology.
[16409192]
Loose femoral tibial components.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 111864 |
MDR Report Key | 111864 |
Date Received | 1997-08-08 |
Date of Report | 1997-06-24 |
Date of Event | 1997-06-24 |
Date Facility Aware | 1997-06-24 |
Report Date | 1997-07-03 |
Date Reported to Mfgr | 1997-07-03 |
Date Added to Maude | 1997-08-12 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
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 | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ADVANTIM TOTAL KNEE |
Generic Name | FEMORAL COMPONENT AND CEMENT FRIENDLY TIBIAL |
Product Code | KRP |
Date Received | 1997-08-08 |
Model Number | FEMUR,TIBIAL,INSERT |
Catalog Number | 18950014,18550300,18903314 |
Lot Number | A026702,A030600,A01014 |
ID Number | * |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Age | * |
Implant Flag | Y |
Date Removed | V |
Device Sequence No | 1 |
Device Event Key | 109835 |
Manufacturer | WRIGHT MEDICAL TECHNOLOGY |
Manufacturer Address | 5677 AIRLINE RD. ARLINGTON TN 38002 US |
Baseline Brand Name | DURAMER ADVANTIM POST STAB LSI TIBIAL INSERT |
Baseline Generic Name | KNEE COMPONENT |
Baseline Catalog No | 1890-3314 |
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 |
Brand Name | ADVANTIM TOTAL KNEE |
Generic Name | FEMORAL COMPONENT AND CEMENT FRIENDLY TIBIAL |
Product Code | JWH |
Date Received | 1997-08-08 |
Model Number | TIBIA |
Catalog Number | * |
Lot Number | A030600, CO-CR |
ID Number | * |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Age | * |
Implant Flag | Y |
Date Removed | V |
Device Sequence No | 2 |
Device Event Key | 109839 |
Manufacturer | WRIGHT MEDICAL TECHA |
Manufacturer Address | 777 AIRLINE RD ARLINGTON TN 38002 US |
Baseline Brand Name | ADVANTIM NONPOROUS POSTERIOR STABILIZED FEMORAL |
Baseline Generic Name | KNEE COMPONENT |
Baseline Model No | * |
Baseline Catalog No | 1895-0014 |
Baseline ID | * |
Baseline Device Family | K J 888.3560 |
Baseline Shelf Life Contained | N |
Baseline Shelf Life [Months] | 96 |
Baseline PMA Flag | N |
Baseline 510K PMN | N |
Baseline Preamendment | Y |
Baseline Transitional | N |
510k Exempt | N |
Brand Name | ADVANTIM TOTAL KNEE |
Generic Name | FEMORAL COMPONENT AND CEMENT FRIENDLY TIBIAL |
Product Code | JWH |
Date Received | 1997-08-08 |
Model Number | INSERT |
Catalog Number | 18903314 |
Lot Number | A01014 |
ID Number | * |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Age | * |
Implant Flag | Y |
Date Removed | V |
Device Sequence No | 3 |
Device Event Key | 109841 |
Manufacturer | WRIGTH MEDICAL TECHNA |
Manufacturer Address | 5677 AIRLINE RD ARLINGTON TN 38002 US |
Baseline Brand Name | ADVANTIM NONPOROUS CF TIBIAL BASE |
Baseline Generic Name | KNEE COMPONENT |
Baseline Model No | * |
Baseline Catalog No | 1885-0300 |
Baseline ID | * |
Baseline Device Family | K J 888.3560 |
Baseline Shelf Life Contained | N |
Baseline Shelf Life [Months] | 96 |
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. Hospitalization; 2. Required No Informationntervention | 1997-08-08 |