Brand Name | MBT TRAY SLEEVE POR M/L 37MM |
Type of Device | MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS INC US |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS 1818910 |
700 orthopaedic dr |
|
warsaw IN 46581 0988 |
|
Manufacturer Contact |
kate
karberg
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
3035526892
|
|
MDR Report Key | 15983793 |
MDR Text Key | 305490219 |
Report Number | 1818910-2022-25439 |
Device Sequence Number | 1 |
Product Code |
NJL
|
UDI-Device Identifier | 10603295026419 |
UDI-Public | 10603295026419 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P830055 |
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 |
12/14/2022 |
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 | 1294-54-100 |
Device Catalogue Number | 129454100 |
Device Lot Number | 529065 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/08/2022
|
Initial Date FDA Received | 12/14/2022 |
Supplement Dates Manufacturer Received | 01/04/2023
|
Supplement Dates FDA Received | 01/05/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/29/2014 |
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 | MBT REVISION CEM TIB TRAY SZ 2; MBT TRAY SLEEVE POR M/L 37MM; PFC SIGMA FEM POST AUG SZ2 4MM; PFC SIGMA FEM POST AUG SZ2 4MM; PFC SIGMA TC3 FEM LEFT SZ2; PFC*SIGMA DIS AUG 4MM,SZ2,LEFT; PFC*SIGMA DIS AUG 4MM,SZ2,LEFT; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S2,12.5; UNIVERSAL STEM 75X12MM FLUTED; UNIVERSAL STEM 75X14MM FLUTED; UNK CEMENT |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 66 YR |
Patient Sex | Female |
Patient Weight | 75 KG |