Brand Name | CUP IMPACTOR BOLT |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
Manufacturer (Section D) |
STRYKER ORTHOPAEDICS-MAHWAH |
325 corporate drive |
mahwah NJ 07430 |
|
Manufacturer (Section G) |
STRYKER ORTHOPAEDICS-CORK |
ida industrial estate |
|
carrigtwohill NA |
|
Manufacturer Contact |
timothy
rice
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 7129088 |
MDR Text Key | 95750662 |
Report Number | 0002249697-2017-03613 |
Device Sequence Number | 1 |
Product Code |
LPH
|
Combination Product (y/n) | N |
PMA/PMN Number | K161569 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,other |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/14/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/31/2021 |
Device Catalogue Number | 1440-2011 |
Device Lot Number | DC 259356 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/22/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/20/2017 |
Initial Date FDA Received | 12/19/2017 |
Supplement Dates Manufacturer Received | 01/17/2018
|
Supplement Dates FDA Received | 02/14/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/02/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|