Brand Name | PINN MULTIHOLE W/GRIPTION 50MM |
Type of Device | PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS |
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 |
kate
karberg
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
3035526892
|
|
MDR Report Key | 14212671 |
MDR Text Key | 290104562 |
Report Number | 1818910-2022-07588 |
Device Sequence Number | 1 |
Product Code |
KWA
|
UDI-Device Identifier | 10603295009979 |
UDI-Public | 10603295009979 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K093646 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/26/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/26/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 1217-30-050 |
Device Catalogue Number | 121730050 |
Device Lot Number | J41U40 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/11/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/09/2019 |
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 | ACTIS COLLARED HIGH SIZE 5; DELTA CER HEAD 12/14 28 MM +5; PINN CAN BONE SCREW 6.5 MMX15 MM; PINN CAN BONE SCREW 6.5 MMX20 MM; PINN CAN BONE SCREW 6.5 MMX20 MM; PINN CAN BONE SCREW 6.5 MMX20 MM; PINN CAN BONE SCREW 6.5 MMX35 MM; PINN LNR CON +4 NEUT 28IDX50OD |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Female |