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 & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
1450 brooks road |
|
memphis TN 38116 |
|
Manufacturer Contact |
markus
poettker
|
schachenallee 29 |
aarau 05001
|
SZ
05001
|
|
MDR Report Key | 6593709 |
MDR Text Key | 76039380 |
Report Number | 1020279-2017-00371 |
Device Sequence Number | 1 |
Product Code |
MBL
|
UDI-Device Identifier | 03596010598332 |
UDI-Public | 03596010598332 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K113848 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
09/28/2017 |
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 | 04/07/2023 |
Device Catalogue Number | 71335752 |
Device Lot Number | 13DM06450 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/08/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/02/2017 |
Initial Date FDA Received | 05/26/2017 |
Supplement Dates Manufacturer Received | 05/02/2017
|
Supplement Dates FDA Received | 09/28/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/09/2013 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Other;
|
Patient Age | 57 YR |
Patient Weight | 51 |
|
|