FDA Adverse Event
Other
Summary report: N
LINK SLED ENDO-MODEL, TIBIAL COMPONENT
MDR report key: 2170164
·
Received June 24, 2011
Report
- Report Number
- 9610548-2011-00018
- Event Type
- Other
- Date Received
- June 24, 2011
- Report Date
- June 21, 2011
- 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
THE DEVICE HISTORY DOCUMENTATION WAS CHECKED AND NO DEVIATIONS FROM OUR SPECIFICATIONS WERE FOUND. WE WILL CONTACT THE CUSTOMER TO RECEIVE MORE DETAILED INFO. THIS EVENT OCCURRED OUTSIDE OF THE U.S. AND INVOLVED A PRODUCT THAT WAS MFG OUTSIDE OF THE U.S. HOWEVER, BECAUSE THE LINK MITUS 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
STRONG WEAR ON THE POLYETHYLENE PART OF THE TIBIAL PLATEAU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINK SLED ENDO-MODEL, TIBIAL COMPONENT | SLED OR UNI-COMPARTMENT PROTHESIS | HSX | WALDEMAR LINK GMBH & CO. KG | 15-2030/02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |