FDA Adverse Event
Injury
Summary report: N
ARTHREX ECLIPSE HUMERAL HEAD, 49/18
MDR report key: 19967189
·
Received August 12, 2024
Report
- Report Number
- 1220246-2024-07154
- Event Type
- Injury
- Date Received
- August 12, 2024
- Date of Event
- July 22, 2024
- Report Date
- February 25, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- QHQ
- UDI-DI
- 00888867060067
- PMA / PMN Number
- K183194
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: G3, H3, H6.
Description of Event or Problem · 0
IT WAS REPORTED THAT ON PICTURES IT WAS FOUND THAT AFTER AN IMPLANTATION IN NOVEMBER 2007 THE COATING OF THE PAN IS ABRADED AND A METALLOSIS IS SUSPECTED. NO INFORMATION PROVIDED BY THE CUSTOMER. UPDATE DW 01-AUG-2024: FURTHER INFORMATION WAS PROVIDED THAT THE PROSTHESIS WAS IMPLANTED IN AGATHARIED FROM PROF. BRUNNER IN OCTOBER 2007. 3 YEARS AGO THE PROSTHESIS STARTED TO MAKING NOISES IN SPECIFIC MOVEMENTS. PROF. BRUNNER HAS DIAGNOSED A WEAR OF THE POLY WITH A METALLOSIS AND OSTEOLYSEN. THE SURGEON ADVISED THE PATIENT TO CLARIFY THE EVENT WITH AN ADDITIONAL ARTHROSCOPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2199933 | ARTHREX ECLIPSE HUMERAL HEAD, 49/18 | TOT ANAT SHOULDR PROSTH, UNCEM | QHQ | ARTHREX, INC. | ARTHREX ECLIPSE HUMERAL HEAD, 49/18 | 0651018 | 00888867060067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |