Brand Name | LPS UNIV TIB HIN INS XXSM 12MM |
Type of Device | LPS AND S-ROM : KNEE TIBIAL INSERT |
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 |
kate
karberg
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
3035526892
|
|
MDR Report Key | 14287113 |
MDR Text Key | 290768530 |
Report Number | 1818910-2022-08204 |
Device Sequence Number | 1 |
Product Code |
KRO
|
UDI-Device Identifier | 10603295079330 |
UDI-Public | 10603295079330 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K091453 |
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 |
05/04/2022 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 1987-27-012 |
Device Catalogue Number | 198727012 |
Device Lot Number | J64G87 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/13/2022 |
Initial Date FDA Received | 05/05/2022 |
Supplement Dates Manufacturer Received | 06/08/2022
|
Supplement Dates FDA Received | 06/09/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/09/2019 |
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 | DEPUY BONE CEMENT; LPS DISTAL FEM COMP XXSM RT; LPS FEM TO SLEEVE ADAPTER +0; MBT REVISION CEM TIB TRAY SZ 3; MBT TRAY SLEEVE POR M/L 29MM); UNIVERSAL STEM 75X16MM FLUTED |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 71 YR |
Patient Sex | Male |
Patient Weight | 80 KG |