FDA Adverse Event
Injury
Summary report: N
NEXGEN LEGACY CONSTRAINED CONDYLAR KNEE ARTICULAR SURFACE WITH LOCKING SCREW
MDR report key: 5782268
·
Received July 11, 2016
Report
- Report Number
- 0001822565-2016-02322
- Event Type
- Injury
- Date Received
- July 11, 2016
- Date of Event
- June 9, 2016
- Report Date
- March 29, 2017
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. DEVICE RECEIVED BUT NOT YET EVALUATED.
Additional Manufacturer Narrative · 1
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION, WHICH WAS INCORRECT AT THE TIME OF INITIAL FOLLOW UP. THE INFORMATION PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MANUFACTURING REPORT NUMBER 0001822565-2016-02321-1
Description of Event or Problem · 1
IT IS REPORTED THAT WHILE THE SURGEON ATTEMPTED TO REMOVE A LOCKING SCREW FROM THE IMPLANTED DEVICE, THE SCREW BROKE AND THREADS WERE LEFT WITHIN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 436749 | NEXGEN LEGACY CONSTRAINED CONDYLAR KNEE ARTICULAR SURFACE WITH LOCKING SCREW | KNEE PROSTHESIS | JWH | ZIMMER, INC. | N/A | 61869913 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |