FDA Adverse Event
Injury
Summary report: N
AS INVERSE HUMERAL PE-INLAY 40-0
MDR report key: 1131864
·
Received August 18, 2008
Report
- Report Number
- 9613350-2008-00095
- Event Type
- Injury
- Date Received
- August 18, 2008
- Date of Event
- September 14, 2007
- Report Date
- July 15, 2008
- Manufacturer
- ZIMMER GMBH
- Product Code
- HSD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED BY PT'S ATTORNEY THAT PT UNDERWENT LEFT TOTAL SHOULDER ARTHROPLASTY IN 2007. POST-OPERATIVELY, A FRACTURE OF THE HUMERUS WAS NOTED AND PT WAS REVISED IN THE NEXT DAY, WHEREIN THE HUMERAL STEM WAS EXCHANGED. POST-OP X-RAYS TAKEN AT ABOUT 13 DAYS LATER, REVEALED THAT THE ARTICULATING GLENOID COMPONENT WAS DISPLACED. PT WAS REVISED AGAIN AT ABOUT 2 DAYS LATER, WHEREIN THE POLYETHYLENE, HUMERAL CUP, GLENOID HEAD, AND HUMERAL STEM WERE EXCHANGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AS INVERSE HUMERAL PE-INLAY 40-0 | ANATOMICAL SHOULDER INVERSE/REVERSE | HSD | ZIMMER GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization| R |