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 |