GLENOID, PE WITH PEG, SMALL
Report
- Report Number
- 1220246-2024-07080
- Event Type
- Malfunction
- Date Received
- August 7, 2024
- Date of Event
- October 1, 2023
- Report Date
- March 7, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- KWS
- UDI-DI
- 00888867057319
- PMA / PMN Number
- K083435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
ADDITIONAL INFORMATION: G3, H3, H6. COMPLAINT ALLEGATION IS NOT CONFIRMED. 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 BONE ENCOUNTERED WERE NOT SPECIFIED. THE DIRECTIONS FOR USE (DFU) FOR ECLIPSE SHOULDER PROTHESIS. D. ADVERSE EFFECTS. 2. ALLERGIES AND OTHER REACTIONS TO DEVICE MATERIALS. 3. LOOSENING OF THE IMPLANT AS A RESULT OF CHANGED CONDITIONS IN LOAD TRANSFER, RESPECTIVELY, FATIGUE WEAR, OR TISSUE REACTION TO THE IMPLANT. LOOSENING IS FREQUENTLY A CONSEQUENCE OF ONE OR SEVERAL OF THE ABOVE LISTED RISK CONDITIONS BUT CAN ALSO BE CAUSED BY INADEQUATE ANCHORING TECHNIQUE. E. WARNINGS. 17. AN ARTIFICIAL JOINT IS SUBJECT TO WEAR AND/OR CAN LOOSEN OVER A PERIOD OF TIME. WEAR AND LOOSENING MAY MAKE IT NECESSARY TO RE-OPERATE ON AN ARTIFICIAL JOINT. H. FACTORS AND RISKS IMPACTING THE SAFETY AND SERVICE LIFE OF THE IMPLANT. 1. PATIENT WEIGHT. AN OVERWEIGHT PATIENT MAY PRESENT ADDITIONAL RISK. 2. EXTREME STRESS OR STRAIN RESULTING FROM WORK OR SPORT-RELATED ACTIVITY. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE OF THE REPORTED FAILURE MAY BE A PATIENT-SPECIFIC EVENT, SPECIFICALLY THE WEAR OF THE DEVICE OVER THE PASSAGE OF 10 YEARS SINCE THE IMPLANTATION SURGERY.
ADDITIONAL INFORMATION: B5, H1, H3, H6.
IT WAS REPORTED THAT AFTER AN INITIAL ECLIPSE SURGERY IN (B)(6) 2013 A REVISION SURGERY OF THE SMALL PEGGED GLENOID WAS NECESSARY AFTER (B)(6) 2023 DUE TO A GLENOID LOOSENING. NO FURTHER INFORMATION RECEIVED. ***UPDATE DW 05-AUG-2024: FURTHER INFORMATION WAS PROVIDED THAT THE AR-9105-01 WITH THE LOT 1215007 WAS IMPLANTED ON (B)(6) 2013. IT WAS FURTHER REPORTED THAT THE GLENOID LOOSENING WAS DIAGNOSED BUT NO REVISION SURGERY TOOK PLACE BY NOW.
UPDATE DW (B)(6) 2024: FURTHER INFORMATION WAS PROVIDED THAT THE AR-9105-01 WITH THE LOT 1215007 WAS IMPLANTED ON (B)(6) 2013. IT WAS FURTHER REPORTED THAT THE GLENOID LOOSENING WAS DIAGNOSED BUT NO REVISION SURGERY TOOK PLACE BY NOW.
UPDATE (B)(6) 13-NOV-2024: THE SURGEON FURTHER REPORTED THAT NO REVISION SURGERY WAS PERFORMED BY NOW AND ITS UNLIKELY THAT A REVISION WILL BE PERFORMED AS THE PATIENT WAS RATHER OLD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264794 | GLENOID, PE WITH PEG, SMALL | PROSTHESIS, SHOULDER, CEMENTED | KWS | ARTHREX, INC. | GLENOID, PE WITH PEG, SMALL | 1215007 | 00888867057319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |