Brand Name | 9/10 ULTAMET 36MM HEADS +0 |
Type of Device | SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS |
Manufacturer (Section D) |
DEPUY INTERNATIONAL LTD - 8010379 |
st. anthony's road |
leeds LS11 8DT |
UK LS11 8DT |
|
Manufacturer (Section G) |
DEPUY INT'L LTD. 8010379 |
st anthonys road |
|
leeds LS11 8 DT |
UK
LS11 8 DT
|
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 12915553 |
MDR Text Key | 281590786 |
Report Number | 1818910-2021-26864 |
Device Sequence Number | 1 |
Product Code |
HWT
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
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 |
12/02/2021 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/22/2012 |
Device Catalogue Number | 962711000 |
Device Lot Number | 2448237 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/17/2021 |
Initial Date FDA Received | 12/02/2021 |
Supplement Dates Manufacturer Received | 12/20/2021
|
Supplement Dates FDA Received | 12/28/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/21/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | 9/10 ULTAMET 36MM HEADS +0.; UNK HIP ACETABULAR LINER. |
Patient Outcome(s) |
Required Intervention;
|