Brand Name | PINN MULTIHOLE W/GRIPTION 58MM |
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 RAYNHAM, A DIV. OF DEPUY ORTHO 1219655 |
325 paramount drive |
|
raynham MA 02767 |
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 13720997 |
MDR Text Key | 286935416 |
Report Number | 1818910-2022-04442 |
Device Sequence Number | 1 |
Product Code |
KWA
|
UDI-Device Identifier | 10603295010012 |
UDI-Public | 10603295010012 |
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 |
03/10/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/10/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 1217-30-058 |
Device Catalogue Number | 121730058 |
Device Lot Number | J2439Z |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/30/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/07/2019 |
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 | APEX HOLE ELIM POSITIVE STOP.; BI MENTUM PFRK PE LINER 28 49.; DELTA CER HEAD 12/14 28MM +1.5.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX35MM.; PINNACLE DM LINER 58_49. |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 72 YR |
Patient Sex | Female |
Patient Weight | 59 KG |