Brand Name | DEPUY1 GENTAMICIN CEMENT 40G |
Type of Device | BONE CEMENT : BONE CEMENT |
Manufacturer (Section D) |
DEPUY CMW - 9610921 |
cornford rd |
blackpool 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 drive |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 10176284 |
MDR Text Key | 195810864 |
Report Number | 1818910-2020-14186 |
Device Sequence Number | 1 |
Product Code |
MBB
|
UDI-Device Identifier | 10603295174264 |
UDI-Public | 10603295174264 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K081163 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Study,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
06/01/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/19/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 5450-31-500 |
Device Catalogue Number | 545031500 |
Device Lot Number | 9322352 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/01/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/08/2020 |
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 | ARTICUL/EZE BALL 28 +5 BR; DEPUY/CMW 2G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; SELF CENT HIP 59X28 GRN; SUMMIT CEMENTED STEM SZ6 HI; ARTICUL/EZE BALL 28 +5 BR; DEPUY/CMW 2G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; SELF CENT HIP 59X28 GRN; SUMMIT CEMENTED STEM SZ6 HI |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 68 YR |
Patient Sex | Male |
Patient Weight | 90 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | White |