Brand Name | UNKNOWN HIP FEMORAL AUGMENT |
Type of Device | HIP FEMORAL AUGMENT |
Manufacturer (Section D) |
DEPUY INTERNATIONAL LTD - 8010379 |
st. anthony's road |
leeds LS11 8DT |
UK LS11 8DT |
|
Manufacturer (Section G) |
LEEDS MFG & MATERIAL WAREHOUSE |
st anthonys road |
|
leeds LS11 8DT |
EI
LS11 8DT
|
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 10120497 |
MDR Text Key | 194055574 |
Report Number | 1818910-2020-13229 |
Device Sequence Number | 1 |
Product Code |
KWY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
05/21/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | UNK HIP FEMORAL AUGMENT |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/21/2020
|
Initial Date FDA Received | 06/04/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD |
Patient Outcome(s) |
Required Intervention;
|