Brand Name | RECLAIM PRX BDY CONE 24X85 |
Type of Device | RECLAIM IMPLANT : HIP FEMORAL STEM |
Manufacturer (Section D) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY IRELAND 9616671 |
loughbeg, ringaskiddy co. |
|
cork |
EI
|
|
Manufacturer Contact |
kate
karberg
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
3035526892
|
|
MDR Report Key | 14251795 |
MDR Text Key | 290397054 |
Report Number | 1818910-2022-07890 |
Device Sequence Number | 1 |
Product Code |
LPH
|
UDI-Device Identifier | 10603295076926 |
UDI-Public | 10603295076926 |
Combination Product (y/n) | N |
Reporter Country Code | NZ |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/29/2022 |
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 | 1975-24-085 |
Device Catalogue Number | 197524085 |
Device Lot Number | J2359M |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/06/2022
|
Initial Date FDA Received | 04/29/2022 |
Supplement Dates Manufacturer Received | 06/30/2022
|
Supplement Dates FDA Received | 07/01/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/01/2019 |
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 | CERCL-CABLE W/CRIMP Ø1.7 SST.; CERCL-CABLE W/CRIMP Ø1.7 SST.; COMPETITOR LIMA CUP.; COMPETITOR LIMA HEAD.; DLT TS CER HD 12/14 40MM +1.5.; LCP PROXFEM HOOKPL 4.5/5 SHAFT 4HO L169.; LOCKSCR Ø5 SELF-TAP L14 SST.; LOCKSCR Ø5 SELF-TAP L14 SST.; LOCKSCR Ø5 SELF-TAP L18 SST.; POSITION-PIN 4.5 F/LCP SST.; POSITION-PIN 4.5 F/LCP SST.; RECLAIM DISTAL TAPERED 15X190A.; RECLAIM PRX BDY CONE 24X85. |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 79 YR |
Patient Sex | Female |