Brand Name | SIGMA HP UNI INS SZ3 7MM RM/LL |
Type of Device | EARLY INTERVENTION : KNEE TIBIAL INSERT |
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 drive |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 9670669 |
MDR Text Key | 189642689 |
Report Number | 1818910-2020-03954 |
Device Sequence Number | 1 |
Product Code |
HRY
|
UDI-Device Identifier | 10603295002833 |
UDI-Public | 10603295002833 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
11/19/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 1024-54-307 |
Device Catalogue Number | 102454307 |
Device Lot Number | J5058U |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/17/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/16/2020
|
Initial Date FDA Received | 02/05/2020 |
Supplement Dates Manufacturer Received | 02/14/2020
|
Supplement Dates FDA Received | 02/19/2020
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/03/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |