Brand Name | LINK SLED PROSTHESIS |
Type of Device | FEMORAL COMPONENT, |
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 | 15333900 |
MDR Text Key | 299038937 |
Report Number | 3004371426-2022-00033 |
Device Sequence Number | 1 |
Product Code |
HSX
|
UDI-Device Identifier | 04026575043910 |
UDI-Public | 04026575043910 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K954186 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Other
|
Remedial Action |
Other |
Type of Report
| Initial,Followup |
Report Date |
08/15/2022 |
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 Operator |
Health Professional
|
Device Expiration Date | 01/31/2022 |
Device Model Number | 15-2020/60 |
Device Catalogue Number | 15-2020/60 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/23/2022 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/15/2022
|
Initial Date FDA Received | 09/01/2022 |
Supplement Dates Manufacturer Received | 08/15/2022
|
Supplement Dates FDA Received | 02/09/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/01/2017 |
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 | 73 YR |
Patient Sex | Male |
Patient Weight | 95 KG |
|
|