Brand Name | LINER 10 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS |
Type of Device | PROSTHESIS, HIP |
Manufacturer (Section D) |
ZIMMER MANUFACTURING B.V. |
turpeaux industrial park |
route #1 km 123.4 bldg #1 |
mercedita PR 00715 |
|
Manufacturer (Section G) |
ZIMMER MANUFACTURING B.V. |
turpeaux industrial park |
route #1 km 123.4 bldg #1 |
mercedita PR 00715 |
|
Manufacturer Contact |
jennifer
rapsavage
|
56 e. bell dr. |
warsaw, IN 46582
|
5745260384
|
|
MDR Report Key | 16627644 |
MDR Text Key | 312126008 |
Report Number | 0002648920-2023-00049 |
Device Sequence Number | 1 |
Product Code |
LPH
|
UDI-Device Identifier | 00889024124721 |
UDI-Public | (01)00889024124721(17)220228(10)63595908 |
Combination Product (y/n) | N |
Reporter Country Code | BR |
PMA/PMN Number | K990135 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/28/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/28/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/28/2022 |
Device Catalogue Number | 00631005032 |
Device Lot Number | 63595908 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 03/15/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/09/2017 |
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) |
Required Intervention;
Hospitalization;
|
Patient Age | 55 YR |
Patient Sex | Female |