GUIDE
Report
- Report Number
- 8030965-2018-54335
- Event Type
- Death
- Date Received
- June 14, 2018
- Report Date
- June 4, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- FZX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
PATIENT ID/INITIALS AND WEIGHT ARE UNKNOWN. DATE OF DEATH IS UNKNOWN. DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN SYNTHES CERCLAGE PASSER/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).
THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: EHLINGER, M. ET AL (2018), VASCULAR COMPLICATION AFTER PERCUTANEOUS FEMORAL CERCLAGE WIRE, ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH, VOL. 104, PAGES 377-381 (FRANCE). THIS IS A CASE REPORT OF A (B)(6)-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF CEMENTED TOTAL HIP ARTHROPLASTY (THA) IN THE LEFT HIP, UNICOMPARTMENTAL MEDIAL ARTHROPLASTY IN THE LEFT KNEE AND BILATERAL PULMONARY EMBOLISM. THE PATIENT WAS HOSPITALIZED AFTER SUFFERING A PERIPROSTHETIC FRACTURE OF THE FEMUR; THE FEMORAL STEM ITSELF WAS STABLE. FRACTURE FIXATION WAS DONE USING UNKNOWN SYNTHES STAINLESS-STEEL, 13-HOLE ANATOMICAL LEFT DISTAL FEMORAL LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATE. FIVE COBALT-CHROME CERCLAGE WIRES WERE ADDED PERCUTANEOUSLY OVER THE FEMORAL STEM TO SECURE THE PROXIMAL FRACTURE FRAGMENTS. THESE WIRES WERE INSERTED USING FORCEPS DEVELOPED SPECIFICALLY FOR PERCUTANEOUS SURGERY (CERCLAGE PASSER, DEPUY SYNTHES, SOLOTHURN, SWITZERLAND). AT POSTOPERATIVE HOUR 6, PATIENT HAD A COLD FOOT WITH COMPLETE SENSORY AND MOTOR DEFICITS AFFECTING THE TIBIAL AND COMMON PERONEAL NERVES. THERE WAS STRONG SUSPICION OF LOWER LIMB ISCHEMIA GIVEN THE ABSENCE OF DISTAL PULSES BUT PRESENCE OF THE FEMORAL PULSE AT THE GROIN FOLD. THE FEMORAL NERVE BLOCK HAD NOT BEEN REMOVED. THERE WAS LACK OF BLOOD FLOW DISTAL IN THE LEFT FEMORAL ARTERY. A CT ANGIOGRAPHY CONFIRMED ACUTE ISCHEMIA OF THE LEFT LOWER LIMB DUE TO OBSTRUCTION OF THE ENTIRE PROXIMAL PORTION OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE SUPERFICIAL FEMORAL ARTERY APPEARED PLICATED INSTEAD OF BEING SURROUNDED BY THE CERCLAGE WIRE. THE LEFT DEEP FEMORAL ARTERY WAS OBSTRUCTED 7 CM FROM THE BIFURCATION. DISTAL BLOOD FLOW WAS COMPLETELY ABSENT BELOW THESE OBSTRUCTIONS. FEMORAL POPLITEAL BYPASS SURGERY WITH PROSTHETIC GRAFT WAS PERFORMED 10 HOURS AFTER THE FRACTURE FIXATION SURGERY. INTRAOPERATIVE MONITORING OF CLINICAL BLOOD PARAMETERS FOUND SEVERE METABOLIC LACTIC ACIDOSIS WITH PH OF 7.1 AND HYPERLACTATEMIA OF 7.8 MMOL/L. IN THE POST-ANESTHESIA CARE UNIT, THE PATIENT WAS STILL OLIGOANURIC AND WAS TRANSFERRED TO SURGICAL INTENSIVE CARE UNIT. DESPITE THE BYPASS, THE LEG WAS STILL ISCHEMIC. THE PATIENT¿S CONDITION DETERIORATED TO MULTIORGAN FAILURE WITH WORSENING OF THE ACUTE KIDNEY FAILURE, PERSISTENCE OF BLOOD DYSCRASIA, RESPIRATORY DISTRESS AND SEVERE LACTIC ACIDOSIS. THE PATIENT DIED A FEW HOURS LATER. CONCOMITANT DEVICE: WIRE FROM AN UNKNOWN MANUFACTURER; LISS PLATE (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR AN UNKNOWN SYNTHES CERCLAGE PASSER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 443389 | GUIDE | FZX | OBERDORF SYNTHES PRODUKTIONS GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 96 YR | Death| R |