MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-10-09 for SMARTSETMV MV ENDURANCE 40 G 3102040 manufactured by Depuy Gmw.
[18491773]
Legal papers allege that bilateral patient suffers from severe pain and disability.
Patient Sequence No: 1, Text Type: D, B5
[18695044]
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 | 1818910-2007-03350 |
| MDR Report Key | 925874 |
| Report Source | 00 |
| Date Received | 2007-10-09 |
| Date of Report | 2007-09-01 |
| Date Mfgr Received | 2007-09-10 |
| Date Added to Maude | 2007-10-16 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GINNY STAMBERGER, MGR |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727333 |
| Manufacturer G1 | DEPUY CMW |
| Manufacturer Street | CORNFORD RD |
| Manufacturer City | BLACKPOOL, LANCASHIRE FY44QQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | FY4 4QQ |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTSETMV MV ENDURANCE 40 G |
| Generic Name | 87JDK |
| Product Code | JDK |
| Date Received | 2007-10-09 |
| Model Number | NA |
| Catalog Number | 3102040 |
| Lot Number | F389Z40 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 898909 |
| Manufacturer | DEPUY GMW |
| Manufacturer Address | CORNFORD RD BLACKPOOL, LANCASHIRE UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-10-09 |