Brand Name | LUBINUS SPII HIP PROSTHESIS SYSTEM |
Type of Device | LUBINUS SPII HIP PROSTHESIS SYSTEM SP II LONG PROSTHESIS STEMS, LEFT COCRMO, |
Manufacturer (Section D) |
WALDEMAR LINK GMBH & CO. KG |
barkhausenweg 10 |
hamburg, 22339 |
GM 22339 |
|
Manufacturer Contact |
annerike
hucklenbroch
|
barkhausenweg 10 |
hamburg, 22339
|
GM
22339
|
|
MDR Report Key | 15355563 |
MDR Text Key | 299279663 |
Report Number | 3004371426-2022-00034 |
Device Sequence Number | 1 |
Product Code |
JDG
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K953653 |
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 |
08/10/2022 |
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 | 06/30/2013 |
Device Model Number | 127-923/26 |
Device Catalogue Number | 127-923/26 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/16/2022 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/10/2022
|
Initial Date FDA Received | 09/05/2022 |
Supplement Dates Manufacturer Received | 08/10/2022
|
Supplement Dates FDA Received | 12/20/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/01/2008 |
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 | 88 KG |
|
|