Brand Name | 40MM OXINIUM MODULAR HEAD |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
MDR Report Key | 8223021 |
MDR Text Key | 132254431 |
Report Number | 1020279-2019-00083 |
Device Sequence Number | 1 |
Product Code |
MBL
|
Combination Product (y/n) | N |
PMA/PMN Number | K093363 |
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 |
06/12/2019 |
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 Catalogue Number | 71342340 |
Device Lot Number | 18FM17934 |
Initial Date Manufacturer Received |
12/17/2018 |
Initial Date FDA Received | 01/07/2019 |
Supplement Dates Manufacturer Received | 12/17/2018
|
Supplement Dates FDA Received | 06/12/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 47 YR |
|
|