Brand Name | R3 3 HOLE ACET SHELL 54MM |
Type of Device | PRSTHSIS,HIP,SEMICONSTRAINED,UNEMNTD,MTAL/POLYMER,PORS |
Manufacturer (Section D) |
SMITH AND NEPHEW INC |
1450 brooks road |
spa park |
memphis TN |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
1450 brooks road |
spa park |
memphis TN |
|
Manufacturer Contact |
markus
poettker
|
schachenallee 29 |
aarau 5001
|
SZ
5001
|
|
MDR Report Key | 6632982 |
MDR Text Key | 77275496 |
Report Number | 3005975929-2017-00173 |
Device Sequence Number | 1 |
Product Code |
MBL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K070756 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,other |
Reporter Occupation |
Attorney
|
Type of Report
| Initial,Followup,Followup |
Report Date |
01/30/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/12/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/10/2020 |
Device Catalogue Number | 71335554 |
Device Lot Number | 10HM08717 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 05/16/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/13/2010 |
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 | ACETABULAR SHELL, PART AND LOT # UNKNOWN; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
|
|