Brand Name | UNK CABLE/WIRE |
Type of Device | EXTREMITY INSTRUMENTS : SIZING/MEASURING INSTRUMENTS |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS INC US |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46581 0988 |
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 13549615 |
MDR Text Key | 285748908 |
Report Number | 1818910-2022-03001 |
Device Sequence Number | 1 |
Product Code |
LXH
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
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 |
Report Date |
02/17/2022 |
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? |
No
|
Device Catalogue Number | UNK CABLE/WIRE |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/04/2022 |
Initial Date FDA Received | 02/17/2022 |
Supplement Dates Manufacturer Received | 02/16/2022 04/01/2022
|
Supplement Dates FDA Received | 02/25/2022 04/01/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 DISTAL FEM COMP XXSM LT; LPS DISTAL FEM COMP XXSM LT; LPS FEM TO SLEEVE ADAPTER +10; LPS SEGMENTAL COMPONENT 25MM; LPS SEGMENTAL COMPONENT 25MM; LPS UNIV TIB HIN INS XXSM 14MM; LPS UNIV TIB HIN INS XXSM 14MM; MBT REVISION CEM TIB TRAY S2.5; MBT REVISION CEM TIB TRAY S2.5; P.F.C.* TIB STM EXT 4/5/6 60MM; P.F.C.* TIB STM EXT 4/5/6 60MM; RESTRICTOR CEMENT FEMORAL BUCK FLANGE; RESTRICTOR CEMENT FEMORAL BUCK FLANGE; SIG TIB CEM STM 13X60 2/2.5/3; SIG TIB CEM STM 13X60 2/2.5/3; TRIATHLON AUGMENT CON; TRIATHLON AUGMENT CONE (5549A140/A916); UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL FEM SLV FUL POR 31MM; UNK CABLE/WIRE; UNK CABLE/WIRE; UNK CABLE/WIRE; UNK KNEE FEMORAL ADAPTOR LPS |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 66 YR |
Patient Weight | 90 KG |