Brand Name | KERAMOS HIP |
Type of Device | LINER,CERAMIC, AL-AL 28X48/50MM |
Manufacturer (Section D) |
ENCORE MEDICAL L.P. |
9800 metric blvd |
austin, tx 78758-5445 |
|
Manufacturer (Section G) |
ENCORE MEDICAL L.P. |
9800 metric blvd |
|
austin, tx 78758-5445 |
|
Manufacturer Contact |
kiersten
soderman
|
9800 metric blvd |
austin, tx 78758-5445
|
|
MDR Report Key | 12882836 |
MDR Text Key | 281338023 |
Report Number | 1644408-2021-01350 |
Device Sequence Number | 1 |
Product Code |
MRA
|
UDI-Device Identifier | 00888912087537 |
UDI-Public | (01)00888912087537 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
01/18/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/31/2012 |
Device Model Number | 498-28-048 |
Device Catalogue Number | 498-28-048 |
Device Lot Number | 53862342 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/03/2021
|
Initial Date FDA Received | 11/29/2021 |
Supplement Dates Manufacturer Received | 12/22/2021
|
Supplement Dates FDA Received | 01/18/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/31/2007 |
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 | 400-01-292 LOT 285312K; 498-01-048 LOT 53812712 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 73 YR |
Patient Sex | Female |