Brand Name | ENDO MODEL ROTATIONAL ROTATION KNEE JOINT |
Type of Device | ROTATING HINGED TOTAL KNEE PROSTHESIS |
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 | 11206480 |
MDR Text Key | 227930589 |
Report Number | 3004371426-2021-00004 |
Device Sequence Number | 1 |
Product Code |
KRO
|
Combination Product (y/n) | N |
PMA/PMN Number | K143179 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Type of Report
| Initial |
Report Date |
12/23/2020 |
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 | 07/31/2023 |
Device Catalogue Number | 15-8020/12 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/04/2021 |
Initial Date Manufacturer Received |
12/23/2020 |
Initial Date FDA Received | 01/21/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/01/2018 |
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;
|
|
|