Brand Name | LINK SLED, TIBIAL PLATEAU, UHMWPE CEMENTED, ALL-POLY |
Type of Device | UNCOATED UNICONDYLAR KNEE TIBIA PROSTHESIS, POLYETHYLENE |
Manufacturer (Section D) |
WALDEMAR LINK GMBH & CO. KG |
barkhausenweg 10 |
hamburg, 22339 |
GM 22339 |
|
Manufacturer Contact |
rebekka
winterhoff
|
barkhausenweg 10 |
hamburg, 22339
|
GM
22339
|
|
MDR Report Key | 12201265 |
MDR Text Key | 262620081 |
Report Number | 3004371426-2021-00020 |
Device Sequence Number | 1 |
Product Code |
KRO
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | K152431 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/30/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/21/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2019 |
Device Catalogue Number | 15-2028/02 |
Device Lot Number | 1432104 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 04/30/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/01/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 82 YR |
Patient Sex | Female |
|
|