Brand Name | POLARCUP SHELL 47 CEMENTED |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
Manufacturer (Section D) |
SMITH & NEPHEW ORTHOPAEDICS AG |
oberneuhofstrasse 10d |
baar 06340 |
SZ 06340 |
|
MDR Report Key | 9687440 |
MDR Text Key | 178375427 |
Report Number | 9613369-2020-00023 |
Device Sequence Number | 1 |
Product Code |
LPH
|
UDI-Device Identifier | 07611996118445 |
UDI-Public | 07611996118445 |
Combination Product (y/n) | N |
PMA/PMN Number | K110135 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
03/10/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/10/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 75100453 |
Device Catalogue Number | 75100453 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 01/28/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | INSERT 75018955, LOT UNKNONW; INSERT 75018955, LOT UNKNONW |
Patient Outcome(s) |
Required Intervention;
|
|
|