ELEOS
Report
- Report Number
- 3013450937-2022-00225
- Event Type
- Injury
- Date Received
- August 25, 2022
- Date of Event
- July 26, 2022
- Report Date
- November 23, 2022
- Manufacturer
- ONKOS SURGICAL
- Product Code
- KRO
- UDI-DI
- B27825000009E0
- PMA / PMN Number
- K161520
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS IN PROGRESS. WHEN IT IS COMPLETE A SUPPLEMENTAL MDR WILL BE SUBMITTED ACCORDINGLY. MULITPLE MDRS WERE SUBMITTED FOR THIS ADVERSE EVENT: 3013450937-2022-00220, 3013450937-2022-00221, 3013450937-2022-00222, 3013450937-2022-00223, 3013450937-2022-00224, 3013450937-2022-00226 AND 3013450937-2022-00227.
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. ON (B)(6) 2022, WHEN COMPLETING THE INVESTIGATION, IT WAS IDENTIFIED THAT TWO OF THE INITIAL MDRS THAT WERE SUBMITTED DID NOT SUCCESSFULLY GO THROUGH AS THEY WERE ASSIGNED DUPLICATE MFR NUMBERS. 3013450937-2022-00349 AND 3013450937-2022-00348 WERE SUBMITTED FOR THESE PARTS. MULTIPLE MDRS WERE SUBMITTED FOR THIS ADVERSE EVENT: 3013450937-2022-00348, 3013450937-2022-0000349, 3013450937-2022-00222, 3013450937-2022-00223, 3013450937-2022-00224, 3013450937-2022-00226 AND 3013450937-2022-00227. THE FOLLOWING SECTIONS WERE UPDATED: H3: DEVICE EVALUATED BY MANUFACTURER UPDATED TO NO. H6: TYPE OF INVESTIGATION CODE UPDATED TO 4110: TREND ANALYSIS. H6: TYPE OF INVESTIGATION CODE UPDATED TO 4117: DEVICE NOT ACCESSIBLE FOR TESTING. H6: INVESTIGATION FINDINGS CODE UPDATED TO 3221: NO FINDINGS AVAILABLE. H6: INVESTIGATION CONCLUSIONS CODE UPDATED TO 4315: CAUSE NOT ESTABLISHED.
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INFECTION AND UNDERWENT A REVISION SURGERY. THE FOLLOWING IMPLANTS WERE REMOVED DURING THE REVISION: ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL BASEPLATE, ELEOS TIBIAL POLY SPACER, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP, ELEOS STEM EXTENSION, ELEOS DISTAL FEMUR, ELEOS TIBIAL BLOCK AUGMENT AND ELEOS CEMENTED SEGMENTAL STEM.
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INFECTION AND UNDERWENT A REVISION SURGERY. THE FOLLOWING IMPLANTS WERE REMOVED DURING THE REVISION: ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL BASEPLATE, ELEOS TIBIAL POLY SPACER, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP, ELEOS STEM EXTENSION, ELEOS DISTAL FEMUR, ELEOS TIBIAL BLOCK AUGMENT AND ELEOS CEMENTED SEGMENTAL STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 481523 | ELEOS | DISTAL FEMUR SIZE: RIGHT, SEGMENTAL | KRO | ONKOS SURGICAL | 25000009E | 1888389 | B27825000009E0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | Required Intervention| H | 25001208E ELEOS TIBIAL POLY SPACER THICKNESS: 8MM| 25002111E ELEOS DISTAL FEMUR AXIAL PIN| CS-13120-03M ELEOS CEMENTED SEGMENTAL STEM| KSP10100E ELEOS STEM EXTENSION, CANAL FILLING| KTAGB210E ELEOS TIBIAL BLOCK AUGMENT SIZE: 2| TB-2202E-01M ELEOS SIZE 2 TIBIAL BASEPLATE| THSMWRS01M ELEOS TIBIAL HINGE W/ROTATIONAL STOP |