Brand Name | ASR UNI FEMORAL IMPL SIZE 49 |
Type of Device | METAL FEMORAL HEAD |
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 |
kate
karberg
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
3035526892
|
|
MDR Report Key | 14499133 |
MDR Text Key | 292700183 |
Report Number | 1818910-2022-09674 |
Device Sequence Number | 1 |
Product Code |
KWA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K040627 |
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
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
05/25/2022 |
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? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 999890249 |
Device Lot Number | 2864985 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/21/2022 |
Initial Date FDA Received | 05/25/2022 |
Supplement Dates Manufacturer Received | 06/17/2022
|
Supplement Dates FDA Received | 06/19/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/18/2009 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-1749/1816-2011 |
Patient Sequence Number | 1 |
Treatment | ADAPTER SLEEVES 12/14 +2; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 59 YR |
Patient Sex | Male |
Patient Weight | 94 KG |