MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 1998-03-06 for KINMTC ROTAT KN TIBL W/O B/PLG 6475-3-933 manufactured by Howmedica Inc..
[94904]
The pt experienced an increasing ache. The implant was revised and it was discovered that the posts have snapped.
Patient Sequence No: 1, Text Type: D, B5
[15839618]
Summary of evaluation: the info provided and the examination results are insufficient to determine the cause of this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610726-1998-00033 |
| MDR Report Key | 154510 |
| Report Source | 01,07 |
| Date Received | 1998-03-06 |
| Date of Report | 1998-03-05 |
| Date of Event | 1997-12-31 |
| Date Facility Aware | 1997-12-31 |
| Report Date | 1998-03-05 |
| Date Mfgr Received | 1998-02-17 |
| Date Added to Maude | 1998-03-10 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KINMTC ROTAT KN TIBL W/O B/PLG |
| Generic Name | IMPLANT |
| Product Code | LGE |
| Date Received | 1998-03-06 |
| Model Number | NA |
| Catalog Number | 6475-3-933 |
| Lot Number | DDVFB |
| ID Number | NA |
| Operator | NOT APPLICABLE |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 150515 |
| Manufacturer | HOWMEDICA INC. |
| Manufacturer Address | 359 VETERANS BLVD RUTHERFORD NJ 07070 US |
| Baseline Brand Name | TIB/BEARING COMP ROT/HIN KNEE |
| Baseline Generic Name | ARTIFICAL KNEE COMPONENT |
| Baseline Model No | NA |
| Baseline Catalog No | 6475-3-933 |
| Baseline ID | NA |
| Baseline Device Family | TIBIAL BEARING |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K811630 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-03-06 |