Brand Name | SELF CENT HIP 45X28 GRY |
Type of Device | HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS INC US |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46581 0988 |
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 19380
|
6107428552
|
|
MDR Report Key | 12956249 |
MDR Text Key | 285159250 |
Report Number | 1818910-2021-27448 |
Device Sequence Number | 1 |
Product Code |
KWY
|
UDI-Device Identifier | 10603295003359 |
UDI-Public | 10603295003359 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K812672 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
11/28/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/07/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 1035-45-000 |
Device Catalogue Number | 103545000 |
Device Lot Number | JK4839 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/22/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/02/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | ARTICUL/EZE BALL 28 +1.5 GR; SELF CENT HIP 45X28 GRY |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Female |