Brand Name | R3 3 HOLE ACET SHELL 54MM |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER |
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 |
yagna
angirish
|
1450 brooks rd |
memphis, TN 38116
|
|
MDR Report Key | 6500207 |
MDR Text Key | 73024388 |
Report Number | 1020279-2017-00275 |
Device Sequence Number | 1 |
Product Code |
MBL
|
UDI-Device Identifier | 03596010598257 |
UDI-Public | 03596010598257 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K070756 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
08/10/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/18/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/31/2023 |
Device Catalogue Number | 71335554 |
Device Lot Number | 14AM01276 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/30/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/02/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | PART#71332754 LOT#14AM02143 R3 XLPE LINER; PART#71343608 LOT#13FM149083 OXINIUM FEM HEAD |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 70 YR |