MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02 report with the FDA on 1997-12-03 for ORTHOLOC ADVANTIM LSI TIBIAL INSERT 1870-3210 manufactured by Wright Medical Technology, Inc..
[74611]
Per sterilization study revision surgery was performed due to alleged effusion and swelling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-1997-00199 |
| MDR Report Key | 136782 |
| Report Source | 02 |
| Date Received | 1997-12-03 |
| Date of Report | 1997-11-04 |
| Date of Event | 1995-04-18 |
| Date Mfgr Received | 1997-11-04 |
| Device Manufacturer Date | 1993-09-01 |
| Date Added to Maude | 1997-12-10 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOLOC ADVANTIM LSI TIBIAL INSERT |
| Generic Name | KNEE COMPONENT |
| Product Code | KRP |
| Date Received | 1997-12-03 |
| Model Number | NA |
| Catalog Number | 1870-3210 |
| Lot Number | 093M902630 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 133622 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 5677 AIRLINE RD. ARLINGTON TN 38002 US |
| Baseline Brand Name | ORTHOLOC ADVANTIM LSI TIBIAL INSERT |
| Baseline Generic Name | KNEE COMPONENT |
| Baseline Model No | NA |
| Baseline Catalog No | 1870-3210 |
| Baseline ID | NA |
| 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 | 1997-12-03 |