Brand Name | UNKNOWN HIP FEMORAL HEAD |
Type of Device | HIP FEMORAL HEAD |
Manufacturer (Section D) |
FINSBURY ORTHOPAEDICS LIMITED |
13 mole business park, randall |
leatherhead, surrey KT22 7BA |
UK
KT22 7BA |
|
Manufacturer (Section G) |
FINSBURY ORTHOPAEDICS LIMITED |
13 mole business park |
randalls road |
leatherhead, surrey KT22 7BA |
UK
KT22 7BA
|
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 10283561 |
MDR Text Key | 199102166 |
Report Number | 1818910-2020-16052 |
Device Sequence Number | 1 |
Product Code |
KWY
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
07/02/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/16/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Catalogue Number | UNK HIP FEMORAL HEAD |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 08/06/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No Answer Provided
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Treatment Data |
Date Received: 07/16/2020 Patient Sequence Number: 1 |
Treatment |
UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
|
|
|
|