Brand Name | OXFORD UNCEMENTED TIBIAL IMPACTOR |
Type of Device | OXFORD UNCEMENTED KNEE SYSTEM INSTRUMENTS |
Manufacturer (Section D) |
BIOMET UK LTD. |
waterton industrial estates |
bridgend CF31 3XA |
UK CF31 3XA |
|
Manufacturer (Section G) |
BIOMET UK LTD. |
waterton industrial estates |
|
bridgend CF31 3XA |
UK
CF31 3XA
|
|
Manufacturer Contact |
christina
arnt
|
56 e. bell dr. |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 15238961 |
MDR Text Key | 298083136 |
Report Number | 3002806535-2022-00356 |
Device Sequence Number | 1 |
Product Code |
HRY
|
UDI-Device Identifier | 00880304525672 |
UDI-Public | (01)00880304525672(11)160808(10)ZB160808 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | N/A |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
10/04/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/17/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 32-422097 |
Device Lot Number | ZB160808 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 10/03/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/08/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Female |