Brand Name | SUMMIT BASIC PRESS FIT SZ 6 |
Type of Device | SUMMIT HIP STEM : HIP FEMORAL STEM |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS INC US |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
Manufacturer (Section G) |
DEPUY INT'L LTD. 8010379 |
st anthonys road |
|
leeds LS11 8 DT |
UK
LS11 8 DT
|
|
Manufacturer Contact |
kate
karberg
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
3035526892
|
|
MDR Report Key | 14205452 |
MDR Text Key | 290049348 |
Report Number | 1818910-2022-07492 |
Device Sequence Number | 1 |
Product Code |
LWJ
|
UDI-Device Identifier | 10603295059721 |
UDI-Public | 10603295059721 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K030122 |
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 |
04/26/2022 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 1570-05-120 |
Device Catalogue Number | 157005120 |
Device Lot Number | D21060137 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/07/2022 |
Initial Date FDA Received | 04/26/2022 |
Supplement Dates Manufacturer Received | 05/09/2022
|
Supplement Dates FDA Received | 05/10/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/17/2021 |
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 | ARTICUL/EZE BALL 28 +8.5 BL; SELF CENT HIP 54X28 BLU; SUMMIT BASIC PRESS FIT SZ 6 |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Male |