FDA Adverse Event
Malfunction
Summary report: N
TRILOGY SHELL WITH HOLES
MDR report key: 3061477
·
Received April 10, 2013
Report
- Report Number
- 2648920-2013-00098
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- February 22, 2013
- Report Date
- March 12, 2013
- Manufacturer
- ZIMMER
- Product Code
- LPH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENT WAS IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. CAUSE CANNOT BE DEFINITIVELY DETERMINED. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. THE RETURNED SHELL WAS MEASURED AND FOUND TO BE WITHIN THE PRINT SPECIFICATIONS.
Description of Event or Problem · 1
IT IS REPORTED THAT AFTER REAMING THE SURGEON IMPLANTED THE SHELL. THE SHELL WAS LOOSE IN THE ACETABULUM. THE SURGEON REAMED UP AND IMPLANTED A LARGER SIZE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149993 | TRILOGY SHELL WITH HOLES | LPH | ZIMMER | 62105165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |