MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2001-09-28 for ADVANTIM(R) THICK UNCONSTRAINED TIBIAL INSERT 1870-0120 manufactured by Wright Medical Technology, Inc..
[233475]
Orig surg: 1998. Medium activity level. Allegedly product condition wasn't the usual. The insert was destroyed at the medical side. The pt allegedly wasn't doing good with the knee. The dr revised only the insert.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2001-00095 |
| MDR Report Key | 353743 |
| Report Source | 01,05 |
| Date Received | 2001-09-28 |
| Date of Report | 2001-08-28 |
| Date of Event | 2001-08-20 |
| Date Facility Aware | 2001-08-28 |
| Date Mfgr Received | 2001-08-28 |
| Date Added to Maude | 2001-10-02 |
| 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 | ADVANTIM(R) THICK UNCONSTRAINED TIBIAL INSERT |
| Generic Name | KNEE COMPONENT |
| Product Code | KRP |
| Date Received | 2001-09-28 |
| Returned To Mfg | 2001-09-19 |
| Model Number | NA |
| Catalog Number | 1870-0120 |
| Lot Number | M321270 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 342961 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 5677 AIRLINE ROAD ARLINGTON TN 38002 US |
| Baseline Brand Name | ADVANTIM THICK UNCONSTRAINED TIBIAL INSERT |
| Baseline Generic Name | KNEE COMPONENT |
| Baseline Catalog No | 1870-0120 |
| 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. Congenital Not Applicablenomaly | 2001-09-28 |