PROXIMAL FEMUR MINIMALLY INVASIVE GROWER (MIG)
Report
- Report Number
- 3004105610-2022-00029
- Event Type
- Injury
- Date Received
- March 16, 2022
- Date of Event
- February 22, 2022
- Report Date
- May 17, 2022
- Manufacturer
- STANMORE IMPLANTS WORLDWIDE
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED DEVICE IS SIMILAR TO A DEVICE APPROVED FOR COMPASSIONATE USE IN THE UNITED STATES. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: FEMORAL HEAD MSFMH/CC2XXX IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. DEVICE NOT RETURNED.
REPORTED EVENT: AN EVENT REGARDING INFECTION OF MIG, PROXIMAL FEMORAL REPLACEMENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED X-RAYS BY CLINICAL CONSULTANT INDICATED: THE IMPLANT IN SITU WAS FOR MIG PROXIMAL FEMORAL REPLACEMENT WHICH WAS INSERTED ON (B)(6) 2017. THE SURGEON REPORTED INFECTION AND LEG LENGTH DISCREPANCY. THE X-RAY AND CT IMAGES PROVIDED SHOW THAT THE IMPLANT HAS BEEN EXTENDED BY 24MM OUT OF ITS MAXIMUM CAPACITY OF 50MM. HOWEVER, THERE IS NO COMPLETE IMAGE FOR THE OTHER LEG, SO THE LEG LENGTH DISCREPANCY CANNOT BE ASSESSED. THE BONE AT LEVEL OF DISTAL STEM HAS SOME EROSIONS WHICH COULD BE CAUSED BY INFECTION BUT NEED TO BE CLINICALLY CONFIRMED. IN OVERALL, THE STEM HAS GOOD FIXATION. THEREFORE, THE RADIOGRAPHIC REVIEW CANNOT CONFIRM THE CLINICAL REPORT. DEVICE HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED THERE HAVE BEEN NO OTHER EVENTS FOR THE STERILE LOT REFERENCED CONCLUSION: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING OPERATIVE REPORTS, PATHOLOGY REPORTS, PROGRESS NOTES AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.
A PATIENT SPECIFIC IMPLANT CASE WAS CREATED FOR THE PATIENT'S LEFT PROXIMAL FEMUR MIG. NOTED IN THE CASE FILE: "INFECTED RECONSTRUCTION AFTER LEFT FEMUR EWING RESECTION. REPLACEMENT OF A MINIMALLY INVASIVE PROXIMAL FEMUR PROSTHESIS WITH A NON INVASIVE GROWING IMPLANT. SECONDARY INFECTION AFTER 3 LENGTHENING PROCEDURE. 9 CM LIMB LENGTH DISCREPANCY."
A PATIENT SPECIFIC IMPLANT CASE WAS CREATED FOR THE PATIENT'S LEFT PROXIMAL FEMUR MIG. NOTED IN THE CASE FILE: "INFECTED RECONSTRUCTION AFTER LEFT FEMUR EWING RESECTION. REPLACEMENT OF A MINIMALLY INVASIVE PROXIMAL FEMUR PROSTHESIS WITH A NON INVASIVE GROWING IMPLANT. SECONDARY INFECTION AFTER 3 LENGTHENING PROCEDURE. 9 CM LIMB LENGTH DISCREPANCY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1508363 | PROXIMAL FEMUR MINIMALLY INVASIVE GROWER (MIG) | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU | JDI | STANMORE IMPLANTS WORLDWIDE | PIN 20503 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Male | Required Intervention| H |