Brand Name | UNKNOWN ACCOLADE II STEM |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
Manufacturer (Section D) |
STRYKER ORTHOPAEDICS-CORK |
ida industrial estate |
carrigtwohill NA |
IE NA |
|
Manufacturer (Section G) |
STRYKER ORTHOPAEDICS-CORK |
ida industrial estate |
|
carrigtwohill NA |
IE
NA
|
|
Manufacturer Contact |
diana
rogers
|
210 centennial avenue |
centennial park, elstree |
borehamwood WD6 3-SJ
|
GB
WD6 3SJ
|
2082386500
|
|
MDR Report Key | 9897817 |
MDR Text Key | 188214307 |
Report Number | 0002249697-2020-00620 |
Device Sequence Number | 1 |
Product Code |
LPH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/30/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/30/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | UNK_SHC |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 03/02/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|