Brand Name | R3 0 DEG XLPE ACET LNR 36MM X 58MM |
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 | 8565623 |
MDR Text Key | 143576352 |
Report Number | 1020279-2019-01712 |
Device Sequence Number | 1 |
Product Code |
MBL
|
UDI-Device Identifier | 03596010598011 |
UDI-Public | 03596010598011 |
Combination Product (y/n) | N |
PMA/PMN Number | K113848 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Type of Report
| Initial,Followup |
Report Date |
06/11/2019 |
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 | 71332758 |
Device Lot Number | 14KM05553 |
Initial Date Manufacturer Received |
04/01/2019 |
Initial Date FDA Received | 04/30/2019 |
Supplement Dates Manufacturer Received | 04/01/2019
|
Supplement Dates FDA Received | 06/11/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | PART# 71303600, LOT 14JM01245; PART# 71332525, LOT 14EM07133; PART# 71335558, LOT 14JM03192; PART# 75100470, LOT A1311990; PART# 71303600, LOT 14JM01245; PART# 71332525, LOT 14EM07133; PART# 71335558, LOT 14JM03192; PART# 75100470, LOT A1311990 |
Patient Outcome(s) |
Death;
Hospitalization;
|
|
|