FDA Adverse Event
Malfunction
Summary report: N
TRIDENT 10 X3 INSERT 36MM ID
MDR report key: 2110156
·
Received May 19, 2011
Report
- Report Number
- 9616680-2011-00319
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- May 2, 2011
- Report Date
- May 2, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LPH
- PMA / PMN Number
- K033716
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
TRIDENT SOLID SHELL WAS IMPACTED AND DOME HOLE INSERTED; HOWEVER, WHEN SURGEON WENT TO IMPACT INSERT SURGEON SAID IT CONTINUED TO "SIT UP". SURGEON CHECKED ACETABULUM AND WAS UNABLE TO SEE ANY TISSUE CAUSING IMPINGEMENT. USED THE INSERT TRIAL WHICH SURGEON SAID "DROPPED IN" DECISION TO OPEN A SECOND IDENTICAL INSERT AND SURGEON CONTINUED TO FIND IT DIFFICULTY TO FULLY SEAT AND IMPACT. EVENTUALLY IMPACTED INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT 10 X3 INSERT 36MM ID | IMPLANT | LPH | STRYKER ORTHOPAEDICS CORK | NA | 35644001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |