FDA Adverse Event
Malfunction
Summary report: N
TRILOGY AB ACETABULAR SYSTEM ALTERNATE BEARING SHELL INSERT
MDR report key: 1121948
·
Received August 13, 2008
Report
- Report Number
- 1822565-2008-00513
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- June 30, 2008
- Report Date
- July 14, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TRILOGY AB ACETABULAR SYSTEM ALTERNATE BEARING SHELL INSERT, LOT #60869009. THE REPORTED MALFUNCTION HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY IN THE PREVIOUS TWO YEARS ON A SAME OR SIMILAR DEVICE. AS A RESULT, THIS REPORT IS BEING SUBMITTED IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE DOCUMENT PUBLISHED BY THE FDA IN MARCH OF 1997. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT WHEN THE LINERS WERE IMPACTED INTO THE SHELL DURING SURGERY IN 2008, THE LINERS BROKE AT THE RIM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRILOGY AB ACETABULAR SYSTEM ALTERNATE BEARING SHELL INSERT | HIP PROSTHESIS | KWB | ZIMMER, INC. | NA | 60869009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |