Brand Name | SIGMA HP DIS FEM CONNECTOR |
Type of Device | KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES |
Manufacturer (Section D) |
DEPUY INTERNATIONAL LTD - 8010379 |
st. anthony's road |
leeds LS11 8DT |
UK LS11 8DT |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46581 0988 |
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 13588056 |
MDR Text Key | 287416904 |
Report Number | 1818910-2022-03419 |
Device Sequence Number | 1 |
Product Code |
LXH
|
UDI-Device Identifier | 10603295225430 |
UDI-Public | 10603295225430 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
02/23/2022 |
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 | 9505-01-238 |
Device Catalogue Number | 950501238 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/10/2022
|
Initial Date FDA Received | 02/23/2022 |
Supplement Dates Manufacturer Received | 03/24/2022
|
Supplement Dates FDA Received | 03/25/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |