FDA Adverse Event
Malfunction
Summary report: N
X3 TRIATHLON CS INSERT #7 13MM
MDR report key: 1915363
·
Received November 17, 2010
Report
- Report Number
- 9610726-2010-00435
- Event Type
- Malfunction
- Date Received
- November 17, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 2, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K063423
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR# 9610726-2010-00434.
Description of Event or Problem · 1
IT WAS REPORTED BY THE SURGEON THAT THE CS INSERT DIDN'T CONNECT TO THE BASEPLATE (ITEM NUMBER 5526-B-700) AT THE POSTERIOR PART. THEREFORE, THE SURGEON TRIED ANOTHER CS INSERT, WHICH ALSO FAILED TO CONNECT TO THE BASEPLATE. THE SURGEON SWITCHED TO A CR INSERT, WHICH CONNECTED TO THE BASEPLATE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X3 TRIATHLON CS INSERT #7 13MM | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | LBD561 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |