Brand Name | LPS UNIV TIB HIN INS XXSM 16MM |
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 46581 0988 |
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 13265902 |
MDR Text Key | 283946451 |
Report Number | 1818910-2022-00941 |
Device Sequence Number | 1 |
Product Code |
KRO
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K091453 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Study,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
01/17/2022 |
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 Catalogue Number | 198727016 |
Device Lot Number | 575270 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/04/2022 |
Initial Date FDA Received | 01/17/2022 |
Supplement Dates Manufacturer Received | 02/01/2022 02/01/2022 03/31/2022
|
Supplement Dates FDA Received | 02/11/2022 02/17/2022 03/31/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/24/2014 |
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 | COMPETITOR CEMENT; LPS CEMENTED STEM 13X125MM STR; LPS DISTAL FEM COMP XXSM LT; LPS UNIV TIB HIN INS XXSM 16MM; LPS XX-SM HINGE PIN; MBT REV TIB TRAY SIZE 2 15MM; SIG TIB CEM STM 13X60 2/2.5/3; UNK KNEE TIBIAL INSERT LPS |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 66 YR |
Patient Sex | Male |
Patient Weight | 125 KG |