Brand Name | GLENOSPHERE HOLDER/ IMPA CTOR |
Type of Device | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
Manufacturer (Section D) |
STRYKER GMBH |
bohnackerweg 1 |
postfach |
selzach 2545 |
CH 2545 |
|
Manufacturer (Section G) |
STRYKER ORTHOPAEDICS-MAHWAH |
325 corporate drive |
|
mahwah NJ 07430 |
|
Manufacturer Contact |
sharon
rivas
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 10380026 |
MDR Text Key | 203496737 |
Report Number | 0008031020-2020-02104 |
Device Sequence Number | 1 |
Product Code |
KWS
|
UDI-Device Identifier | 07613327101027 |
UDI-Public | 07613327101027 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130895 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/07/2020 |
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 Model Number | 5901-1168 |
Device Catalogue Number | 5901-1168 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/15/2020 |
Initial Date FDA Received | 08/07/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 Age | 76 YR |