Brand Name | DLT TS CER HD 12/14 36MM +1.5 |
Type of Device | ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS INC US |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
Manufacturer (Section G) |
DEPUY IRELAND 9616671 |
loughbeg, ringaskiddy co. |
|
cork |
EI
|
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 12924956 |
MDR Text Key | 281737778 |
Report Number | 1818910-2021-27100 |
Device Sequence Number | 1 |
Product Code |
KWA
|
UDI-Device Identifier | 10603295033653 |
UDI-Public | 10603295033653 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K073570 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/03/2021 |
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 Model Number | 1365-36-710 |
Device Catalogue Number | 136536710 |
Device Lot Number | 9830774 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/19/2021 |
Initial Date FDA Received | 12/03/2021 |
Supplement Dates Manufacturer Received | 12/20/2021
|
Supplement Dates FDA Received | 12/30/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/01/2021 |
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 |
Treatment | ALTRX +4 NEUT 36IDX56OD; DLT TS CER HD 12/14 36MM +1.5 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 55 YR |
Patient Sex | Male |
Patient Weight | 101 KG |