Brand Name | ENDO-MODEL SL |
Type of Device | FEMORAL COMPONENT, INTRACONDYLAR MODULAR CEMENTED ROTATIONAL KNEE |
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 | 12030803 |
MDR Text Key | 257138628 |
Report Number | 3004371426-2021-00017 |
Device Sequence Number | 1 |
Product Code |
KRO
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K151008 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/11/2021 |
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 | 08/31/2022 |
Device Model Number | 16-2825/21 |
Device Catalogue Number | 16-2825/21 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/22/2021 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/11/2021
|
Initial Date FDA Received | 06/21/2021 |
Supplement Dates Manufacturer Received | 06/11/2021
|
Supplement Dates FDA Received | 11/15/2021
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/01/2020 |
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 | 64 YR |
Patient Sex | Male |
Patient Weight | 115 KG |
|
|