ECLIPSE TRUNION,43 MM TPS CTD
Report
- Report Number
- 1220246-2024-07770
- Event Type
- Injury
- Date Received
- September 20, 2024
- Date of Event
- September 1, 2016
- Report Date
- May 27, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- QHQ
- UDI-DI
- 00888867059863
- PMA / PMN Number
- K183194
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 501
Narratives
ADDITIONAL INFORMATION.
ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
UPDATE DW 24-SEP-2024: FURTHER INFORMATION WAS PROVIDED THAT THE CUSTOMER HAS REMOVED THE GLENOID ARTHROSCOPIC. IT WAS THEN FURTHER REPORTED THAT DUE TO AN OMARTHROSE AN ADDITIONAL SURGERY WAS PERFORMED AND AN INVERSE SHOULDER-TEP WAS IMPLANTED.
IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY ON (B)(6)2016 AFTER THE INITIAL IMPLANTATION ON 08TH NOVEMBER 2013 DUE TO A BROKE OUT GLENOID. NO FURTHER INFORMATION RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226521 | ECLIPSE TRUNION,43 MM TPS CTD | TOT ANAT SHOULDR PROSTH, UNCEM | QHQ | ARTHREX, INC. | ECLIPSE TRUNION,43 MM TPS CTD | 2501236506 | 00888867059863 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |