Brand Name | BICON-PLUS PE INSERT ANTIL 5/32 NON-CEM |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
Manufacturer (Section D) |
SMITH & NEPHEW ORTHOPAEDICS AG |
schachenallee 29 |
baar 06340 |
SZ 06340 |
|
MDR Report Key | 9252692 |
MDR Text Key | 164488312 |
Report Number | 9613369-2019-00081 |
Device Sequence Number | 1 |
Product Code |
LPH
|
Combination Product (y/n) | N |
PMA/PMN Number | K992154 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial,Followup,Followup |
Report Date |
04/07/2020 |
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 | 12/28/2012 |
Device Catalogue Number | 75003589 |
Device Lot Number | 0512027640 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/30/2019 |
Initial Date FDA Received | 10/29/2019 |
Supplement Dates Manufacturer Received | 09/30/2019 09/30/2019
|
Supplement Dates FDA Received | 11/05/2019 04/08/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | 75002756 SL-PLUS STEM LATERAL 4,LOT: C0602511 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 68 YR |
|
|