ELEOS
Report
- Report Number
- 3013450937-2021-00001
- Event Type
- Malfunction
- Date Received
- January 18, 2021
- Date of Event
- December 14, 2020
- Report Date
- March 23, 2021
- Manufacturer
- ONKOS SURGICAL
- Product Code
- KRO
- UDI-DI
- B278FB1315203M0
- PMA / PMN Number
- K161520
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
THE INSTRUMENT INVOLVED IN THE COMPLAINT INVESTIGATED IN PCR 12212020 WAS SENT TO JTL AMERICA, A TESTING SUPPLIER ON ONKOS' ASL, FOR VISUAL INSPECTION, DIMENSIONAL INSPECTION, FRACTURE ANALYSIS, AND METALLURGY ANALYSIS. THE REPORT FROM THE ANALYSIS HAD THE FOLLOWING CONCLUSION FOR THE VISUAL INSPECTION AND FRACTURE ANALYSIS: "THE ORTHOPEDIC IMPLANT SAMPLE FAILED DUE TO UNIDIRECTIONAL BENDING FATIGUE. FATIGUE CRACKING IS DUE TO CYCLIC LOADING, TYPICALLY BELOW THE YIELD STRENGTH OF THE MATERIAL. THE FRACTURE INITIATED FROM THE 6 O'CLOCK POSITION, ALONG THE FEMORAL STEM SLOT PLANE AND PROPAGATED THROUGH THE THICKNESS OF THE SAMPLE UNTIL FINAL OVERLOAD OCCURRED. SECONDARY CRACKS WERE OBSERVED NEAR THE INITIATION SITE. MECHANICAL WEAR WAS OBSERVED ON THE OUTER SURFACE OF THE NON-COATED REGIONS OF THE IMPLANT SAMPLE, INDICATING THE SAMPLE EXPERIENCED UNANTICIPATED BENDING LOAD. DUE TO THE INCONSISTENT PLASMA COATING, THE OUTER SURFACE OF THE SAMPLE EXHIBITED ROUGH TEXTURE. THE OBSERVED ROUGH SURFACE ON THE SAMPLE MAY HAVE ASSISTED THE FATIGUE CRACK INITIATION BY ACTING AS A STRESS RISER, A GEOMETRIC CHANGE OR MECHANICAL NOTCH THAT [INTENSIFY] THE LOCAL STRESSES." THE METALLURGY ANALYSIS CAME TO THE FOLLOWING CONCLUSION: "THE SAMPLE WAS CONSISTENT WITH 6AL-4V TITANIUM ALLY PER ASTM F136-13. THE AVERAGE HARDNESS OF THE SAMPLE WAS 35 HRC. NO HARDNESS SPECIFICATION WAS PROVIDED FOR COMPARISON. THE MICROSTRUCTURE OF THE SAMPLE CONSISTED OF EQUIAXED ALPHA PHASE AND INTERGRANULAR BETA PHASE. NO METALLURGIC ANOMALIES DETRIMENTAL TO THE MECHANICAL PROPERTIES WERE OBSERVED." DIMENSIONAL INSPECTION WAS PERFORMED FOR ALL RELEVANT MEASURABLE FEATURES. SOME FEATURES WERE UNABLE TO BE MEASURED DUE TO THE FRACTURE TO THE PART. SOME FEATURES WERE NOT MEASURED AS THEY WERE DEEMED NOT RELEVANT TO THE FRACTURE. ALL FEATURES THAT WERE MEASURED WERE FOUND TO BE WITHIN SPECIFICATION EXCEPT FOR THE DIAMETER OF DATUM B (SEE ATTACHED DRAWING). THE FEATURE WAS FOUND TO BE 0.0003" OVER SPECIFICATION. HOWEVER, INSPECTION PERFORMED AT PHILLIPS PRECISION INC, WHERE THE IMPLANT IS MANUFACTURED, FOUND THE FEATURE TO BE CONFORMING WHEN IT WAS INSPECTED VIA AN AIR GAUGE DURING FIRST ARTICLE INSPECTION AS WELL AS AN IN-PROCESS INSPECTION WHICH MEASURED THE FEATURE AT A FREQUENCY OF 100 PERCENT FOR THE LOT.
A FEMALE PATIENT OF UNKNOWN AGE UNDERWENT A REVISION SURGERY PERFORMED BY DR. (B)(6)ON (B)(6) 2020 TO REPLACE A FEMORAL STEM IMPLANT THAT FRACTURED. DURING THE REVISION SURGERY, THE FRACTURED IMPLANT AND OTHER IMPLANTS THAT HAD BEEN PLACED DURING THE PRIMARY SURGERY WERE EXPLANTED AND REPLACED.
THE ROOT CAUSE OF THE FRACTURE OF THE IMPLANT IS STILL PENDING INVESTIGATION. A FOLLOW UP WILL BE SUBMITTED WHEN MORE INFORMATION IS AVAILABLE ABOUT THE PATIENT AND WHEN TESTING OF THE FRACTURED IMPLANT IS CONDUCTED.
A FEMALE PATIENT OF UNKNOWN AGE UNDERWENT A REVISION SURGERY PERFORMED BY DR. (B)(6) ON (B)(6) 2020 TO REPLACE A FEMORAL STEM IMPLANT THAT FRACTURED. DURING THE REVISION SURGERY, THE FRACTURED IMPLANT AND OTHER IMPLANTS THAT HAD BEEN PLACED DURING THE PRIMARY SURGERY WERE EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87131 | ELEOS | SEGMENTAL STEM, 13MM X 152MM, BOWED, CANAL FILLING | KRO | ONKOS SURGICAL | FB-13152-03M | 82293 | B278FB1315203M0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |