Brand Name | ENDO MODEL |
Type of Device | ENDO-M. MOD.ROTATION KNEE,JOINT COMP.UNIT W. PATELLAR FLANGE, SMALL, LEFT |
Manufacturer (Section D) |
WALDEMAR LINK GMBH & CO. KG |
barkhausenweg 10 |
hamburg, 22339 |
GM 22339 |
|
Manufacturer Contact |
sagar
shetty
|
barkhausenweg 10 |
hamburg, 22339
|
GM
22339
|
|
MDR Report Key | 14559719 |
MDR Text Key | 293073573 |
Report Number | 3004371426-2022-00017 |
Device Sequence Number | 1 |
Product Code |
KRO
|
Combination Product (y/n) | N |
Reporter Country Code | SP |
PMA/PMN Number | K143179 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Other
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
05/12/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 15-2816/12 |
Device Catalogue Number | 15-2816/12 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/12/2022 |
Initial Date FDA Received | 06/01/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/01/2021 |
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) |
Other;
|
|
|