ACCOLADE TMZF FEMORAL RASP SIZE 3
Report
- Report Number
- 0002249697-2014-02131
- Event Type
- Malfunction
- Date Received
- June 5, 2014
- Date of Event
- May 15, 2014
- Report Date
- May 15, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE PATIENT IS (B)(6). AN EVENT REGARDING AN ACCOLADE TMZF STEM THAT SAT PROUD INVOLVING AN ACCOLADE TMZF RASP WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED MEDICAL INFORMATION WAS SUBMITTED TO A CONSULTING CLINICIAN WHO DEEMED IT INSUFFICIENT FOR A MEDICAL REVIEW. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED.
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. HOSPITAL RETAINED DEVICE.
IT WAS REPORTED DURING INITIAL SURGERY OF RIGHT HIP THERE WAS AN ISSUE WITH ACCOLADE TMZF STEM. DOCTOR WENT TO BROACH #3 STEM. IMPLANT AND STEM SAT PROUD ABOUT 1CM. DOCTOR TOOK OUT NUMBER 3 AND INSERT 2 1/2 STEM, THIS LED TO A DELAY IN SURGERY.
IT WAS REPORTED DURING INITIAL SURGERY OF RIGHT HIP THERE WAS AN ISSUE WITH ACCOLADE TMZF STEM. DOCTOR WENT TO BROACH #3 STEM. IMPLANT AND STEM SAT PROUD ABOUT 1CM. DOCTOR TOOK OUT NUMBER 3 AND INSERT 2 1/2 STEM, THIS LED TO A DELAY IN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329514 | ACCOLADE TMZF FEMORAL RASP SIZE 3 | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |