MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2006-01-04 for UNKNOWN ULNAR COMPONENT manufactured by Depuy Orthopaedics, Inc..
[408179]
Pt was revised due to infection and loosening of the humeral and ulnar components.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1818910-2006-00131 |
MDR Report Key | 660182 |
Report Source | 05,08 |
Date Received | 2006-01-04 |
Date of Report | 2005-12-09 |
Date of Event | 2005-12-09 |
Date Facility Aware | 2005-12-09 |
Report Date | 2005-12-09 |
Date Mfgr Received | 2005-12-09 |
Date Added to Maude | 2006-01-09 |
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 | 700 ORTHOPAEDIC DR |
Manufacturer City | WARSAW IN 46581098 |
Manufacturer Country | US |
Manufacturer Postal Code | 46581 0988 |
Single Use | 3 |
Remedial Action | OT |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | UNKNOWN ULNAR COMPONENT |
Generic Name | TOTAL ELBOW REPLACEMENT |
Product Code | KWJ |
Date Received | 2006-01-04 |
Model Number | NA |
Catalog Number | UNK |
Lot Number | UNK |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | 3 YR |
Device Eval'ed by Mfgr | R |
Implant Flag | Y |
Date Removed | V |
Device Sequence No | 1 |
Device Event Key | 649619 |
Manufacturer | DEPUY ORTHOPAEDICS, INC. |
Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 465810988 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2006-01-04 |