Brand Name | LPS FEM TO SLEEVE ADAPTER +10 |
Type of Device | LPS AND S-ROM : KNEE FEMORAL ACCESSORY |
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 | 13548837 |
MDR Text Key | 285747960 |
Report Number | 1818910-2022-02981 |
Device Sequence Number | 1 |
Product Code |
MBH
|
UDI-Device Identifier | 10603295078500 |
UDI-Public | 10603295078500 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K071417 |
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,Followup |
Report Date |
02/17/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/17/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 1987-06-010 |
Device Catalogue Number | 198706010 |
Device Lot Number | 443591 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/31/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/30/2013 |
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 XSM RT; LPS FEM TO SLEEVE ADAPTER +10; LPS UNIV TIB HIN INS XSM 23MM; MBT REV TIB TRAY SIZE 2 15MM; MBT TRAY SLEEVE POR M/L 53MM; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001; UNIVERSAL FEM SLV FUL POR 40MM; UNIVERSAL STEM 75X18MM FLUTED; UNIVERSAL STEM 75X20MM FLUTED |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 64 YR |
Patient Weight | 154 KG |