MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02 report with the FDA on 2005-12-07 for PRSVN MB TIB TRAY LM/RL CEM S4 149826004 manufactured by Depuy-cork, A Div. Of Depuy Orthopaedics.
[415116]
Clinical report states the patient was revised due to pain, the tibial component was found to be loose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2005-02613 |
| MDR Report Key | 650879 |
| Report Source | 02 |
| Date Received | 2005-12-07 |
| Date of Report | 2005-11-14 |
| Date of Event | 2004-01-07 |
| Date Facility Aware | 2005-11-14 |
| Report Date | 2005-11-14 |
| Date Mfgr Received | 2005-11-14 |
| Date Added to Maude | 2005-12-12 |
| 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 | GINNY STAMBERGER, MGR |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727333 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS |
| Manufacturer Street | LOUGHBEY |
| Manufacturer City | RINGASKIDDY COUNTY, CORK |
| Manufacturer Country | EI |
| 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 LM/RL CEM S4 |
| Generic Name | TOTAL KNEE PROSTHESIS |
| Product Code | MBD |
| Date Received | 2005-12-07 |
| Model Number | NA |
| Catalog Number | 149826004 |
| Lot Number | YGY06 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 640351 |
| Manufacturer | DEPUY-CORK, A DIV. OF DEPUY ORTHOPAEDICS |
| Manufacturer Address | LOUGHBEY RINGASKIDDY COUNTY, CORK EI |
| Baseline Brand Name | PRSVN MB TIB TRAY LM/RL CEM S4 |
| Baseline Generic Name | KNEE INSERT |
| Baseline Model No | NA |
| Baseline Catalog No | 149826004 |
| 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 | 1. Required No Informationntervention | 2005-12-07 |