Brand Name | LPS UNIV TIB HIN INS XSM 12MM |
Type of Device | LPS AND S-ROM : 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 |
kate
karberg
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
3035526892
|
|
MDR Report Key | 13558330 |
MDR Text Key | 285805062 |
Report Number | 1818910-2022-03069 |
Device Sequence Number | 1 |
Product Code |
KRO
|
UDI-Device Identifier | 10603295079392 |
UDI-Public | 10603295079392 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K091453 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
02/18/2022 |
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 Operator |
Health Professional
|
Device Model Number | 1987-27-112 |
Device Catalogue Number | 198727112 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/10/2022 |
Initial Date FDA Received | 02/18/2022 |
Supplement Dates Manufacturer Received | 03/18/2022 04/21/2022
|
Supplement Dates FDA Received | 03/24/2022 04/22/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
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 LT (EX PKT).; LPS UNIV TIB HIN INS XSM 12MM.; UNIV FEM SLEEVE CEM 20MM.; UNK KNEE FEMORAL ADAPTOR LPS.; UNK KNEE FEMORAL ADAPTOR LPS.; UNK KNEE FEMORAL AUGMENT LPS.; UNK KNEE FEMORAL AUGMENT LPS.; UNK KNEE FEMORAL LPS.; UNK KNEE LPS.; UNK KNEE LPS.; UNK KNEE STEM LPS.; UNK KNEE STEM LPS. |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Female |