ELEOS
Report
- Report Number
- 3013450937-2021-00250
- Event Type
- Injury
- Date Received
- November 4, 2021
- Date of Event
- October 7, 2021
- Report Date
- January 3, 2022
- Manufacturer
- ONKOS SURGICAL
- Product Code
- KRO
- UDI-DI
- B27825002111E0
- PMA / PMN Number
- K161520
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING SUBMITTED TO INCLUDE ADDITIONAL INFORMATION. THE INVESTIGATION IS COMPLETE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE ALLEGED INFECTION COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORDS AND STERILIZATION BATCH RECORDS WERE REVIEWED AND NO ISSUES DURING MANUFACTURING OR STERILIZATION WERE IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. IF ANY ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL MDR WILL BE FILED ACCORDINGLY. THE FOLLOWING SECTIONS WERE UPDATED: H3: DEVICE EVALUATED BY MANUFACTURER UPDATED TO NO. H6: TYPE OF INVESTIGATION CODE UPDATED TO 3331: ANALYSIS OF PRODUCTION RECORDS. H6: TYPE OF INVESTIGATION CODE UPDATED TO 4111: COMMUNICATION/INTERVIEWS. H6: TYPE OF INVESTIGATION CODE UPDATED TO 4110: TREND ANALYSIS. H6: TYPE OF INVESTIGATION CODE UPDATED TO 4114: DEVICE NOT RETURNED. H6: TYPE OF INVESTIGATION CODE UPDATED TO 4117: DEVICE NOT ACCESSIBLE FOR TESTING. H6: TYPE OF INVESTIGATION CODE UPDATED TO 4109: HISTORICAL DATA ANALYSIS. H6: INVESTIGATION FINDINGS CODE UPDATED TO 213: NO DEVICE PROBLEM FOUND. H6: INVESTIGATION CONCLUSIONS CODE UPDATED TO 4315: CAUSE NOT ESTABLISHED.
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLEGED INFECTION AND UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE FOLLOWING ELEOS IMPLANTS WERE REVISED: MALE-FEMALE MIDSECTION (40MM). DISTAL FEMUR, TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE ORIGINAL SURGERY: CANAL-FILLING SEGMENTAL STEM (11X152MM), TIBIAL BASEPLATE, AND CANAL-FILLING STEM EXTENSION (12X100MM). NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.
THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MDR WILL BE SUBMITTED ACCORDINGLY. MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT: #3013450937-2021-00246, #3013450937-2021-00247, #3013450937-2021-00248, #3013450937-2021-00249, #3013450937-2021-00251, #3013450937-2021-00252, #3013450937-2021-00253.
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLEGED INFECTION AND UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE FOLLOWING ELEOS IMPLANTS WERE REVISED: MALE-FEMALE MIDSECTION (40MM). DISTAL FEMUR, TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE ORIGINAL SURGERY: CANAL-FILLING SEGMENTAL STEM (11X152MM), TIBIAL BASEPLATE, AND CANAL-FILLING STEM EXTENSION (12X100MM). NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1650882 | ELEOS | DISTAL FEMUR AXIAL PIN, ONE SIZE | KRO | ONKOS SURGICAL | 25002111E | 1857435 | B27825002111E0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Hospitalization| R | P/N 25000009E, ELEOS DISTAL FEMUR| P/N 25001040E, ELEOS MALE-FEMALE MIDSECTION| P/N 25001208E, ELEOS TIBIAL POLY SPACER| P/N 25002101E, ELEOS TIBIAL HINGE COMPONENT| P/N 25002202E, ELEOS TIBIAL BASEPLATE| P/N FB-11152-03M, ELEOS CANAL-FILLING STEM| P/N KSP11100E, ELEOS STEM EXTENSION| P/N 25000009E, ELEOS DISTAL FEMUR| P/N 25001040E, ELEOS MALE-FEMALE MIDSECTION| P/N 25001208E, ELEOS TIBIAL POLY SPACER| P/N 25002101E, ELEOS TIBIAL HINGE COMPONENT| P/N 25002202E, ELEOS TIBIAL BASEPLATE| P/N FB-11152-03M, ELEOS CANAL-FILLING STEM| P/N KSP11100E, ELEOS STEM EXTENSION |