FDA Adverse Event
Injury
Summary report: N
UNKNOWN PERSONA IMPLANT
MDR report key: 6021016
·
Received October 12, 2016
Report
- Report Number
- 0001822565-2016-03656
- Event Type
- Injury
- Date Received
- October 12, 2016
- Report Date
- June 27, 2017
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative · 1
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS COMPLAINT WAS FOR A REQUEST FOR PRODUCT IDENTIFICATION ONLY. THERE WAS NO ALLEGED DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR PERFORMANCE OF THE PRODUCT. AS SUCH, THIS INFORMATION IS CONSIDERED AN INQUIRY AND THE COMPLAINT FILE IS BEING CLOSED AS NOT A COMPLAINT.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PATIENT IS UNDERGOING A REVISION DUE TO UNK REASONS AFTER A KNEE ARTHROPLASTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675105 | UNKNOWN PERSONA IMPLANT | KNEE PROSTHESIS | JWH | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |