Brand Name | LPS UNIV TIB HIN INS XSM 21MM |
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 |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 13632821 |
MDR Text Key | 286322682 |
Report Number | 1818910-2022-03787 |
Device Sequence Number | 1 |
Product Code |
KRO
|
UDI-Device Identifier | 10603295079439 |
UDI-Public | 10603295079439 |
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 |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/01/2022 |
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 | 1987-27-121 |
Device Catalogue Number | 198727121 |
Device Lot Number | J7738H |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/16/2022 |
Initial Date FDA Received | 03/01/2022 |
Supplement Dates Manufacturer Received | 04/01/2022
|
Supplement Dates FDA Received | 04/01/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/26/2020 |
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 | LPS CEMENTED STEM 14X125MM STR; LPS DISTAL FEM COMP XSM RT; LPS SEGMENTAL COMPONENT 25MM; LPS UNIV TIB HIN INS XSM 21MM; MBT REV TIB TRAY SIZE 4 15MM; MBT TRAY SLEEVE CEM M/L 29MM; S&N RESTRICTOR CEMENT BUCK FLANGE; S&N RESTRICTOR CEMENT BUCK FLANGE; SIG TIB CEM STM 13X60 2/2.5/3; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 67 YR |
Patient Weight | 107 KG |