MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2006-08-15 for PRSVN MB TIB TRAY LM/RL CEM S3 149826003 manufactured by Depuy Orthopaedics, Inc., Depuy-cork.
[17022576]
Pt revised due to loosening of the tibial component.
Patient Sequence No: 1, Text Type: D, B5
[17303791]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2006-02314 |
| MDR Report Key | 748764 |
| Report Source | 05,08 |
| Date Received | 2006-08-15 |
| Date of Report | 2006-07-18 |
| Date of Event | 2006-07-18 |
| Date Facility Aware | 2006-07-18 |
| Report Date | 2006-07-18 |
| Date Mfgr Received | 2006-07-18 |
| Date Added to Maude | 2006-08-16 |
| 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, INC. |
| Manufacturer Street | LOUGHBEG RINGASKIDDY COUNTY |
| Manufacturer City | 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 S3 |
| Generic Name | TOTAL KNEE REPLACEMENT |
| Product Code | MBD |
| Date Received | 2006-08-15 |
| Model Number | NA |
| Catalog Number | 149826003 |
| Lot Number | 1029997 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 736545 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC., DEPUY-CORK |
| Manufacturer Address | LOUGHBEG RINGASKIDDY COUNTY, CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-08-15 |