MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-07-29 for TRIAXIAL TOTAL ELBOW SYSTEM HUMERAL COMPONENT 87-2011 manufactured by Johnson And Johnson Professionals, Inc..
[67371]
Prosthesis began to break up and revision surgery was necessary to correct the problem.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1219655-1997-00109 |
MDR Report Key | 108535 |
Report Source | 00 |
Date Received | 1997-07-29 |
Date of Report | 1997-07-29 |
Date Mfgr Received | 1997-07-08 |
Device Manufacturer Date | 1992-06-01 |
Date Added to Maude | 1997-07-30 |
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 | 0 |
Reporter Occupation | ATTORNEY |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 0 |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | TRIAXIAL TOTAL ELBOW SYSTEM HUMERAL COMPONENT |
Generic Name | PROSTHETIC ELBOW |
Product Code | KWJ |
Date Received | 1997-07-29 |
Model Number | NA |
Catalog Number | 87-2011 |
Lot Number | 113LL |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Implant Flag | Y |
Date Removed | U |
Device Sequence No | 1 |
Device Event Key | 106672 |
Manufacturer | JOHNSON AND JOHNSON PROFESSIONALS, INC. |
Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 1997-07-29 |