MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-06-29 for DURA DURATION A/P TIB MED 22 6642-1-722 manufactured by Howmedica Inc..
[140291]
Revision surgery has been reported due to dislodged insert. Even though doctor reinserted it and it seemed to be very stable, he removed it and put a new one in.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2219689-1999-00150 |
| MDR Report Key | 229877 |
| Report Source | 07 |
| Date Received | 1999-06-29 |
| Date of Report | 1999-06-29 |
| Date of Event | 1999-05-02 |
| Date Mfgr Received | 1999-06-02 |
| Device Manufacturer Date | 1997-05-01 |
| Date Added to Maude | 1999-07-06 |
| 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 | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURA DURATION A/P TIB MED 22 |
| Generic Name | IMPLANT |
| Product Code | LSH |
| Date Received | 1999-06-29 |
| Returned To Mfg | 1999-06-17 |
| Model Number | NA |
| Catalog Number | 6642-1-722 |
| Lot Number | UWYAB |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | Y |
| Device Sequence No | 1 |
| Device Event Key | 222941 |
| Manufacturer | HOWMEDICA INC. |
| Manufacturer Address | 359 VETERANS BLVD. RUTHERFORD NJ 07070 US |
| Baseline Brand Name | DURACON DURATION A/P LIPPED TIBIAL INSERT |
| Baseline Generic Name | ARTIFICIAL KNEE COMPONENT |
| Baseline Model No | NA |
| Baseline Catalog No | 6642-1-722 |
| Baseline ID | NA |
| Baseline Device Family | TIBIAL INSERT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K936292 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-06-29 |