Brand Name | M/H 3HOLE RLC SHL NRS 54MM/L24 |
Type of Device | PROSTHESIS, HIP |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
warsaw IN 46582 |
|
MDR Report Key | 7765515 |
MDR Text Key | 116532377 |
Report Number | 0001825034-2018-07385 |
Device Sequence Number | 1 |
Product Code |
LZO
|
Combination Product (y/n) | N |
PMA/PMN Number | PK921181 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,study |
Type of Report
| Initial,Followup |
Report Date |
10/18/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/08/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 13-104154 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 10/18/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Treatment | UNK STEM, HEAD, LINER, UNK LOT |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 48 YR |
Patient Weight | 91 |
|
|