Brand Name | LINK ENDO-MODEL ROTATION KNEE JOINT PROSTHESIS WITH POREX SURFACE MODIFICATION |
Type of Device | ROTATING HINGED TOTAL KNEE PROSTHESIS |
Manufacturer (Section D) |
WALDEMAR LINK GMBH & CO. KG |
barkhausenweg 10 |
hamburg, 22339 |
GM 22339 |
|
Manufacturer (Section G) |
WALDEMAR LINK GMBH & CO. KG |
barkhausenweg 10 |
|
hamburg, 22339 |
GM
22339
|
|
Manufacturer Contact |
omid
rahmatian
|
barkhausenweg 10 |
hamburg, 22339
|
GM
22339
|
|
MDR Report Key | 8978841 |
MDR Text Key | 157784916 |
Report Number | 3004371426-2019-00127 |
Device Sequence Number | 1 |
Product Code |
KRO
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K152431 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/07/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/01/2019 |
Device Model Number | 15-9024/12 |
Device Catalogue Number | 15-9024/12 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/07/2017 |
Initial Date Manufacturer Received |
07/07/2017 |
Initial Date FDA Received | 09/10/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/01/2014 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 70 YR |
Patient Weight | 100 |