Brand Name | LINKSYMPHOKNEE |
Type of Device | LINKSYMPHOKNEE SYSTEM, L-SHAPED FEMORAL AUGMENT MEDIAL-RIGHT/LATERAL-LEFT, |
Manufacturer (Section D) |
WALDEMAR LINK GMBH & CO. KG |
barkhausenweg 10 |
hamburg, 22339 |
GM 22339 |
|
Manufacturer Contact |
lisa
effe
|
barkhausenweg 10 |
hamburg, 22339
|
GM
22339
|
|
MDR Report Key | 16794171 |
MDR Text Key | 313813848 |
Report Number | 3004371426-2023-00023 |
Device Sequence Number | 1 |
Product Code |
HRY
|
UDI-Device Identifier | 04026575258123 |
UDI-Public | 04026575258123 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K202924 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Other
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
04/19/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 880-325/13 |
Device Catalogue Number | 880-325/13 |
Device Lot Number | 1910003 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/19/2023
|
Initial Date FDA Received | 04/24/2023 |
Supplement Dates Manufacturer Received | 04/19/2023
|
Supplement Dates FDA Received | 08/03/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/01/2022 |
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 Age | 78 YR |
Patient Sex | Female |
|
|