Brand Name | PINN STRAIGHT CUP IMPACTOR |
Type of Device | HIP INSTRUMENTS : IMPACTORS |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS INC US |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46581 0988 |
|
Manufacturer Contact |
kara
ditty-bovard
|
1210 ward avenue |
west chester, PA 19380-0988
|
6103142063
|
|
MDR Report Key | 9506271 |
MDR Text Key | 184373434 |
Report Number | 1818910-2019-124505 |
Device Sequence Number | 1 |
Product Code |
MRA
|
UDI-Device Identifier | 10603295098980 |
UDI-Public | 10603295098980 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P070026 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
12/04/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/20/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 2217-50-041 |
Device Catalogue Number | 221750041 |
Device Lot Number | SO2036538 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/17/2019 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/23/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/02/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |