FDA Adverse Event
Other
Summary report: N
LINK SLED ENDO-MODEL, TIBIAL COMPONENT
MDR report key: 2792452
·
Received October 10, 2012
Report
- Report Number
- 9610548-2012-00018
- Event Type
- Other
- Date Received
- October 10, 2012
- Date of Event
- October 10, 2012
- Report Date
- October 10, 2012
- Manufacturer
- WALDEMAR LINK GMBH & CO. KG
- Product Code
- HSX
- PMA / PMN Number
- K954186
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
WE ARE ALREADY IN CONTACT WITH THE SURGEON TO GET MORE INFORMATION TO PERFORM AN INVESTIGATION (E.G. X-RAY IMAGES, COMPLAINT SAMPLE). THIS EVENT OCCURRED OUTSIDE OF THE U.S. AND INVOLVED A PRODUCT THAT WAS MANUFACTURED OUTSIDE OF THE U.S. AND INVOLVED A PRODUCT THAT WAS MANUFACTURED OUTSIDE OF THE U.S. HOWEVER, BECAUSE THE LINK SLED ENDO-MODEL, TIBIAL COMPONENT ALSO IS MARKETED IN THE U.S., LINK IS SUBMITTING THIS MDR TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.
Description of Event or Problem · 1
THE PATIENT'S LAWYER INFORMED US ABOUT THIS ISSUE. HE REPORTED WEAR OF THE UHMWPE MATERIAL WITHIN A SHORT TIME PERIOD OF IMPLANTATION. THE REVISION SURGERY WILL TAKE PLACE TODAY ((B)(6) 2012).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINK SLED ENDO-MODEL, TIBIAL COMPONENT | SLED OR UNI-COMPARTMENT PROSTHESIS | HSX | WALDEMAR LINK GMBH & CO. KG | 15-2030/09 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| R |