FDA Adverse Event
Malfunction
Summary report: N
LINK MITUS ENDO-MODEL
MDR report key: 2193484
·
Received July 29, 2011
Report
- Report Number
- 9610548-2011-00021
- Event Type
- Malfunction
- Date Received
- July 29, 2011
- Date of Event
- November 19, 2008
- Report Date
- July 29, 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 UHMWPE TIBIA PLATEAU SHOWS STRONG WEAR, WHICH IS NOT LOCATED IN THE MIDDLE OF THE PLATEAU AND LEADS TO THE ASSUMPTION THAT THE IMPLANT WAS NOT ALIGNED CORRECTLY TO THE ANATOMICAL STRUCTURES OF THE PT. BESIDE THIS, THE PT IS OBESE. THIS EVENT OCCURRED OUTSIDE THE U.S. AND INVOLVED A PRODUCT THAT WAS MFG OUTSIDE OF THE U.S. HOWEVER, BECAUSE THE LINK MITUS ENDO-MODEL 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 OF PE INSERT AFTER ONE YEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINK MITUS ENDO-MODEL | SLED OR UNI-COMPARTMENT PROSHESIS | HSX | WALDEMAR LINK GMBH & CO. KG | 15-2030/11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization |