Brand Name | SMARTSET GHV GENTAMICIN 20G |
Type of Device | BONE CEMENT : BONE CEMENT |
Manufacturer (Section D) |
DEPUY CMW - 9610921 |
cornford rd. |
blackpool IN FY4 4 QQ |
UK FY4 4QQ |
|
Manufacturer (Section G) |
DEPUY CMW - 9610921 |
cornford rd |
|
blackpool FY4 4 QQ |
UK
FY4 4QQ
|
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 13000537 |
MDR Text Key | 282201452 |
Report Number | 1818910-2021-27840 |
Device Sequence Number | 1 |
Product Code |
MBB
|
Combination Product (y/n) | Y |
Reporter Country Code | GM |
PMA/PMN Number | K033563 |
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 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/14/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 3095020 |
Device Lot Number | 8736663 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/08/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/31/2018 |
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 | ATTUNE CEMENTED STEM 14X80MM; ATTUNE PS FB INSRT SZ 6 5MM; ATTUNE PS FEM RT SZ 6 CEM; ATUNE CRS FB TIB BASE SZ 6 CEM; SMARTSET GHV GENTAMICIN 20G; SMARTSET GHV GENTAMICIN 40G |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 62 YR |
Patient Sex | Male |
Patient Weight | 151 KG |