FDA Adverse Event
Malfunction
Summary report: N
GMRS EXTENSION PIECE 60MM
MDR report key: 3191723
·
Received June 26, 2013
Report
- Report Number
- 0002249697-2013-02086
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Date of Event
- March 12, 2013
- Report Date
- June 3, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 1
UPDATED CATALOG NUMBER BASED ON ADDITIONAL INFORMATION RECEIVED. AN EVENT REGARDING LENGTH DISCREPANCY BETWEEN TRIAL AND IMPLANT INVOLVING A GMRS EXTENSION PIECE IMPLANT WAS REPORTED. THE REPORTED LENGTH DISCREPANCY BETWEEN TRIAL AND IMPLANT COMPONENTS ONLY CONCERNS THE TRIAL EXTENSION PIECES. THERE IS NO ALLEGATION OR EVIDENCE THAT THERE IS A LENGTH DISCREPANCY ISSUE WITH THE EXTENSION PIECE IMPLANT ITSELF. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.
Description of Event or Problem · 1
TRIALS DID NOT MATCH IMPLANTS.
Description of Event or Problem · 1
TRIALS DID NOT MATCH IMPLANTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290215 | GMRS EXTENSION PIECE 60MM | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other |