Brand Name | R3 20 DEG XLPE ACET LNR 36MM X 52MM |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS |
Manufacturer (Section D) |
SMITH AND NEPHEW, INC. |
1450 brooks road |
memphis, tennessee |
memphis 38116 |
|
MDR Report Key | 7924622 |
MDR Text Key | 122292914 |
Report Number | 1020279-2018-01970 |
Device Sequence Number | 1 |
Product Code |
MBL
|
UDI-Device Identifier | 03596010598332 |
UDI-Public | 03596010598332 |
Combination Product (y/n) | N |
PMA/PMN Number | K113848 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
11/29/2018 |
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 | 71335752 |
Device Lot Number | 17KM13354 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/05/2018 |
Initial Date FDA Received | 10/01/2018 |
Supplement Dates Manufacturer Received | 09/05/2018
|
Supplement Dates FDA Received | 11/29/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
|
|