Brand Name | ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM |
Type of Device | ROTATING HINGED TOTAL KNEE PROSTHESIS |
Manufacturer (Section D) |
WALDEMAR LINK GMBH & CO. KG |
barkhausenweg 10 |
hamburg, 22339 |
GM 22339 |
|
MDR Report Key | 9243493 |
MDR Text Key | 165961395 |
Report Number | 3004371426-2019-00131 |
Device Sequence Number | 1 |
Product Code |
KRO
|
Combination Product (y/n) | N |
PMA/PMN Number | K152431 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Type of Report
| Initial,Followup |
Report Date |
10/02/2019 |
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 | 06/30/2020 |
Device Catalogue Number | 15-3817/11 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/12/2019 |
Initial Date Manufacturer Received |
10/02/2019 |
Initial Date FDA Received | 10/28/2019 |
Supplement Dates Manufacturer Received | 10/02/2019
|
Supplement Dates FDA Received | 01/24/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 76 YR |
Patient Weight | 72 |
|
|