Brand Name | EA DELTA CER INSERT 36IDX52OD |
Type of Device | PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
warsaw IN 46582 0988 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic dr. |
warsaw, IN 46582-0988
|
5743725905
|
|
MDR Report Key | 7244033 |
MDR Text Key | 99109137 |
Report Number | 1818910-2018-52848 |
Device Sequence Number | 1 |
Product Code |
KWA
|
Combination Product (y/n) | N |
Reporter Country Code | LG |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
01/17/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/06/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/30/2021 |
Device Catalogue Number | 121881752 |
Device Lot Number | 8445142 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/03/2018 |
Date Device Manufactured | 09/01/2017 |
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;
|
Patient Age | 64 YR |