MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-09-04 for DURAMER(R) ADVANTIM(R) POST STAB LSI TIBIAL INSERT 1890-3210 manufactured by Wright Medical Technology, Inc..
[210192]
Original date of surgery in 1998. Allegedly base plate (left knee) cracked on medial side from anterior to posterior. 3 weeks ago, pt had terrible pain. Pt did great before that. Allegedly x-rays shows line in back part of locking detail.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2001-00084 |
| MDR Report Key | 350379 |
| Report Source | 05,06 |
| Date Received | 2001-09-04 |
| Date of Report | 2001-07-31 |
| Date of Event | 2001-07-27 |
| Date Facility Aware | 2001-07-31 |
| Date Mfgr Received | 2001-07-31 |
| Device Manufacturer Date | 1997-09-01 |
| Date Added to Maude | 2001-09-10 |
| 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 |
| 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 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURAMER(R) ADVANTIM(R) POST STAB LSI TIBIAL INSERT |
| Generic Name | KNEE COMPONENT |
| Product Code | KRP |
| Date Received | 2001-09-04 |
| Returned To Mfg | 2001-08-08 |
| Model Number | NA |
| Catalog Number | 1890-3210 |
| Lot Number | 097A069777 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 339674 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 5677 AIRLINE ROAD ARLINGTON TN 38002 US |
| Baseline Brand Name | DURAMER ADVANTIM POST STAB LSI TIBIAL INSERT |
| Baseline Generic Name | KNEE COMPONENT |
| Baseline Catalog No | 1890-3210 |
| 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 | 2001-09-04 |