Brand Name | DJO SHOULDER REPLACEMENT BASEPLATE |
Type of Device | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
Manufacturer (Section D) |
DJO / ENCORE MEDICAL, L. P. |
|
|
MDR Report Key | 12961240 |
MDR Text Key | 282040573 |
Report Number | MW5105924 |
Device Sequence Number | 1 |
Product Code |
KWS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/06/2021 |
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 | 508-32-204 |
Device Lot Number | 769P1852, 769P1778 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 12/07/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 68 YR |
Patient Sex | Female |
Patient Weight | 88 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | White |
|
|