Brand Name | ENDO-MODEL MODULAR KNEE SYSTEM |
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 |
annerike tizia
hucklenbroch
|
barkhausenweg 10 |
hamburg, 22339
|
GM
22339
|
|
MDR Report Key | 15474271 |
MDR Text Key | 300560337 |
Report Number | 3004371426-2022-00036 |
Device Sequence Number | 1 |
Product Code |
KRO
|
UDI-Device Identifier | 04026575316038 |
UDI-Public | 04026575316038 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K143179 |
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 |
09/01/2022 |
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 Expiration Date | 06/30/2023 |
Device Model Number | 15-2816/12 |
Device Catalogue Number | 15-2816/12 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
09/01/2022 |
Initial Date FDA Received | 09/23/2022 |
Supplement Dates Manufacturer Received | 09/01/2022
|
Supplement Dates FDA Received | 12/14/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/01/2018 |
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 | 65 YR |
Patient Sex | Female |
Patient Weight | 82 KG |
|
|