Brand Name | CERAMIC BALL HEAD 32L |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, CERAMIC, CEMENTED OR NON-POROUS, UNCEMENTED |
Manufacturer (Section D) |
SMITH & NEPHEW ORTHOPAEDICS AG |
oberneuhofstrasse 10d |
baar 6340 |
SZ 6340 |
|
Manufacturer (Section G) |
SMITH & NEPHEW ORTHOPAEDICS AG |
schachenallee 29 |
|
aarau 5001 |
SZ
5001
|
|
Manufacturer Contact |
|
MDR Report Key | 6546938 |
MDR Text Key | 74474153 |
Report Number | 9613369-2017-00024 |
Device Sequence Number | 1 |
Product Code |
LZO
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K070928 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
07/20/2017 |
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 Expiration Date | 11/12/2020 |
Device Model Number | 16163 |
Device Catalogue Number | 75004174 |
Device Lot Number | C1312447 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/20/2017 |
Initial Date FDA Received | 05/05/2017 |
Supplement Dates Manufacturer Received | Not provided 04/21/2017 04/21/2017
|
Supplement Dates FDA Received | 06/20/2017 07/04/2017 07/20/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/12/2013 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 59 YR |
Patient Weight | 98 |