Brand Name | PINN SECTOR 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 INT'L LTD. 8010379 |
st anthonys road |
|
leeds IN LS11 8 DT |
UK
LS11 8 DT
|
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 13505347 |
MDR Text Key | 285391201 |
Report Number | 1818910-2022-02630 |
Device Sequence Number | 1 |
Product Code |
KWA
|
UDI-Device Identifier | 10603295010333 |
UDI-Public | 10603295010333 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K093646 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Study,Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
02/10/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 1217-32-058 |
Device Catalogue Number | 121732058 |
Device Lot Number | 9785210 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/01/2022 |
Initial Date FDA Received | 02/10/2022 |
Supplement Dates Manufacturer Received | 03/18/2022
|
Supplement Dates FDA Received | 03/21/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/18/2021 |
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 | ALTRX NEUT 36IDX58OD; ARTICULEZE M HEAD 36MM +5; CORAIL AMT COLLAR SIZE 13 |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Male |
Patient Weight | 101 KG |