FDA Adverse Event
Injury
Summary report: N
NEXGEN ALL POLY PATELLA
MDR report key: 5392782
·
Received January 27, 2016
Report
- Report Number
- 2648920-2016-00016
- Event Type
- Injury
- Date Received
- January 27, 2016
- Report Date
- December 29, 2015
- Manufacturer
- ZIMMER, TURPEAUX INDUSTRIAL PARK
- Product Code
- JWH
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). OTHER DEVICES USED: CATALOG #00591603000, NEXGEN FLUTED TIBIAL COMPONENT, LOT #61922822; MANUFACTURED AT ZIMMER BIOMET, INC., (B)(4). CATALOG #00591704010, NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE, LOT #61853882; MANUFACTURED AT ZIMMER BIOMET, INC., (B)(4). CATALOG #00576401452, NEXGEN LPS-FLEX FEMORAL COMPONENT, LOT #61915330, MANUFACTURED AT ZIMMER BIOMET LTD., (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative · 1
UPON RECEIPT OF ADDITIONAL INFORMATION, THIS REPORT WILL BE COMPLETED UNDER MANUFACTURING REPORT NUMBER 0001822565-2016-02833.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING DISLOCATION OF THE IMPLANT WITH IT POPPING OUT OF PLACE AND A CASE OF EXTREME SKIN IRRITATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51519 | NEXGEN ALL POLY PATELLA | JWH | JWH | ZIMMER, TURPEAUX INDUSTRIAL PARK | N/A | 61947275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |