MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-01-08 for PRSVN MB TIB TRAY RM/LL CEM S4 149825004 manufactured by Depuy International, Ltd..
[341152]
Implants reported to be failing. Sales rep reports loosening. Pt has not been revised as of yet. Bilateral pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2004-00013 |
| MDR Report Key | 508660 |
| Report Source | 07 |
| Date Received | 2004-01-08 |
| Date of Report | 2003-12-09 |
| Date of Event | 2001-05-14 |
| Date Facility Aware | 2004-01-08 |
| Report Date | 2004-01-08 |
| Date Mfgr Received | 2003-12-09 |
| Date Added to Maude | 2004-01-30 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HANS KUSSEROW, MGR |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | * |
| Manufacturer G1 | DEPUY INTERNATIONAL, LTD. |
| Manufacturer Street | ST. ANTHONY'S ROAD |
| Manufacturer City | LEEDS LS118DT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS11 8DT |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRSVN MB TIB TRAY RM/LL CEM S4 |
| Generic Name | TOTAL KNEE PROSTHESIS |
| Product Code | MBD |
| Date Received | 2004-01-08 |
| Model Number | NA |
| Catalog Number | 149825004 |
| Lot Number | 1036895 |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 497607 |
| Manufacturer | DEPUY INTERNATIONAL, LTD. |
| Manufacturer Address | ST. ANTHONY'S ROAD LEEDS UK LS11 8DT |
| Baseline Brand Name | PRSVN MB TIB TRAY RM/LL CEM S4 |
| Baseline Generic Name | KNEE INSERT |
| Baseline Model No | NA |
| Baseline Catalog No | 149825004 |
| Baseline ID | NA |
| Baseline Device Family | PRSVN MB INSERT |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | Y |
| Premarket Approval | P9100 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-01-08 |