Brand Name | PERFORM REV INSERT SZ 1/2, 36MM DIA, +0 VE |
Type of Device | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED |
Manufacturer (Section D) |
TORNIER INC |
10801 nesbitt avenue s |
bloomington MN 55437 |
|
Manufacturer (Section G) |
TORNIER INC |
10801 nesbitt avenue s |
|
bloomington MN 55437 |
|
Manufacturer Contact |
anna
jusinski
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 16950446 |
MDR Text Key | 315438253 |
Report Number | 0001649390-2023-00101 |
Device Sequence Number | 1 |
Product Code |
PAO
|
UDI-Device Identifier | 00846832077991 |
UDI-Public | 00846832077991 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K201315 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Study |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
08/11/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/17/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | DWS1360 |
Device Catalogue Number | DWS1360 |
Device Lot Number | CZ0821340 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 07/17/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/08/2022 |
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 |
Patient Outcome(s) |
Other;
|
Patient Age | 64 YR |
Patient Weight | 66 KG |
|
|