UNKNOWN COBB ELEVATOR
Received Aug 12, 2025 · Event occurred Dec 9, 2021
Report 1038671-2025-02736 · MDR key 22785365
Device
Generic name
Elevator
Manufacturer
Exactech, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
68 YR · Female
- Damage to Ligament(s)
- Damage to Ligament(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE LEFT SIDE. DURING THE PROCEDURE, THE SURGEON NOTED HAVING BEEN TOO AGGRESSIVE WITH THE COBB ELEVATOR WHILE RELEASING THE PES ANSERINE FOR SOFT TISSUE BALANCING, RESULTING IN AN INJURY TO THE MEDIAL COLLATERAL LIGAMENT. THE INJURY WAS RESOLVED WITH THE SELECTION OF CONSTRAINED CONDYLAR TOTAL KNEE REPLACEMENT COMPONENTS. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Additional Manufacturer Narrative
THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A REVIEW OF MANUFACTURING DATA WAS UNABLE TO BE PERFORMED AS THE LOT INFORMATION OF THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.