BI POLAR RADIAL CUP 22MM DIA
Received Oct 17, 2024 · Event occurred Mar 27, 2024
Report 3000931034-2024-00626 · MDR key 20468780
Device
Generic name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Manufacturer
Tornier S.a.s.Catalog number
DTJ022
Lot number
7994AZ
Product problems
- Positioning Failure
- Adverse Event Without Identified Device or Use Problem
- Positioning Failure
- Adverse Event Without Identified Device or Use Problem
Patient
0 DA · Male
- Perforation
- Perforation
Narrative
Description of Event or Problem
AS REPORTED: "WELBOW STUDY SUBJECT : (B)(6). DURING THE SURGERY INVOLVING THE CRF II IMPLANT, AN INTRA-OPERATIVE COMPLICATION WAS OBSERVED. THE PATIENT EXPERIENCED A DEFECT IN THE RADIAL BONE CUT. THIS EVENT WAS REPORTED AS A SERIOUS ADVERSE EVENT THAT REQUIRED INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT OR DAMAGE. IN MEDICAL OBSERVATION: INDICATION TO REPEAT THE CUT OF AT LEAST 3MM, CEMENTATION OF A NEW STEM, REINSERTION OF THE EXTERNAL COLLATERAL PLANE, PROCEDURE: CHANGE OF LEFT RADIAL HEAD PROSTHESIS, 3MM CUT, REINSERTION OF EXTERNAL COLLATERAL PLANE. THIS RECORD IS COVERING THIS INTRA-OP COMPLICATION. MANAGEMENT IN THE OPERATING ROOM ON (B)(6) 2024 FOR ARTHROPLASTY OF THE RADIAL HEAD AND REINSERTION OF THE LATERAL PLANE ON ANCHOR. POST-OPERATIVE FOLLOW-UP RADIOGRAPHS SHOWED TOO MUCH PROSTHETIC CROWDING. NEED FOR REVISION SURGERY TO CUT THE NECK OF THE RADIUS AND REIMPLANT A NEW PROSTHESIS. A NEW CRF II IMPLANT WAS USED. STRYKER REFERENCE # (B)(4) IS COVERING THIS REVISION SURGERY."
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
AS REPORTED: "WELBOW STUDY SUBJECT : (B)(6). DURING THE SURGERY INVOLVING THE CRF II IMPLANT, AN INTRA-OPERATIVE COMPLICATION WAS OBSERVED. THE PATIENT EXPERIENCED A DEFECT IN THE RADIAL BONE CUT. THIS EVENT WAS REPORTED AS A SERIOUS ADVERSE EVENT THAT REQUIRED INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT OR DAMAGE. IN MEDICAL OBSERVATION: INDICATION TO REPEAT THE CUT OF AT LEAST 3MM, CEMENTATION OF A NEW STEM, REINSERTION OF THE EXTERNAL COLLATERAL PLANE, PROCEDURE: CHANGE OF LEFT RADIAL HEAD PROSTHESIS, 3MM CUT, REINSERTION OF EXTERNAL COLLATERAL PLANE. THIS RECORD IS COVERING THIS INTRA-OP COMPLICATION. MANAGEMENT IN THE OPERATING ROOM ON (B)(6) 2024 FOR ARTHROPLASTY OF THE RADIAL HEAD AND REINSERTION OF THE LATERAL PLANE ON ANCHOR. POST-OPERATIVE FOLLOW-UP RADIOGRAPHS SHOWED TOO MUCH PROSTHETIC CROWDING. NEED FOR REVISION SURGERY TO CUT THE NECK OF THE RADIUS AND REIMPLANT A NEW PROSTHESIS. A NEW CRF II IMPLANT WAS USED. STRYKER REFERENCE # (B)(4) IS COVERING THIS REVISION SURGERY."
Additional Manufacturer Narrative
PLEASE NOTE CORRECTION TO H6 (DEVICE CODE). THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WERE PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. IT DID REVEAL THAT INTRA-OPERATIVELY, FREQUENT RADIOSCOPIC CHECKS ALLOW THE POSITION OF THE PROSTHESIS TO BE CHECKED. IN THE EVENT DESCRIPTION IT¿S MENTION THAT THE POST-OPERATIVE FOLLOW-UP RADIOGRAPHS SHOWED TOO MUCH PROSTHETIC CROWDING. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE EVENT WAS CAUSED BY AN INSUFFICIENT RESECTION OF THE RADIUS. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.