MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1997-07-08 for DURAMER BRAND ADVANTIM LSI TIBIAL INSERT 1880-3312 manufactured by Wright Medical Technology, Inc..
[17640300]
Additional info: upon further investigation, it was found by the user facility that co product did not cause or contribute to this serious injury; therefore, the mdr was not required.
Patient Sequence No: 1, Text Type: N, H10
[21693048]
Pt allegedly had distal fracture of femur. A tibial rod procedure was performed and insert was removed during this procedure. At time of removal, surgeon allegedly saw extreme wear (pitting) of the tibial insert. He said he did not see any loose bodies.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-1997-00095 |
| MDR Report Key | 104813 |
| Report Source | 05,07 |
| Date Received | 1997-07-08 |
| Date of Report | 1997-07-07 |
| Date of Event | 1997-06-01 |
| Date Mfgr Received | 1997-06-13 |
| Device Manufacturer Date | 1995-09-01 |
| Date Added to Maude | 1997-07-15 |
| 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 | DURAMER BRAND ADVANTIM LSI TIBIAL INSERT |
| Generic Name | KNEE COMPONENT |
| Product Code | KRP |
| Date Received | 1997-07-08 |
| Returned To Mfg | 1997-06-19 |
| Model Number | NA |
| Catalog Number | 1880-3312 |
| Lot Number | 095A030631 |
| 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 | 103077 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 5677 AIRLINE RD. ARLINGTON TN 38002 US |
| Baseline Brand Name | DURAMER BRAND ADVANTIM LSI TIBIAL INSERT |
| Baseline Generic Name | KNEE COMPONENT |
| Baseline Catalog No | 1880-3312 |
| 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 | 1997-07-08 |