UNKNOWN KNEE INSTRUMENT
Received May 28, 2025 · Event occurred May 9, 2021
Report 0001822565-2025-01567 · MDR key 22095938
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
(B)(4). D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. H3- CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY DUE TO POST TRAUMATIC FEMORAL DEGENERATIVE JOINT DISEASE AND OSTEOARTHRITIS. SUBSEQUENTLY, DURING THE PROCEDURE THE PROXIMAL PATELLA FRACTURED DURING THE EXPOSURE OF THE TIBIA. THE PATELLAR BONE WAS TOO OSTEOPOROTIC AND THIN TO RESURFACE; THEREFORE, WAS REDUCING AND REINFORCED USING A MESH EXTENSOR MECHANISM RECONSTRUCTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.
Additional Manufacturer Narrative
THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. UPDATED: B4, B5, D2, G1, G3, G6, H1, H2, H3, H6, AND H11. CORRECTED: H6 (COMPONENT CODES). NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT UNDERWENT ARTHROPLASTY FOR A TRAUMATIC FEMORAL INJURY UNDER GENERAL ANESTHESIA (ASA III). INTRAOPERATIVELY, A PATELLA FRACTURE OCCURRED DURING TIBIAL EXPOSURE, WITH THE PATELLA DEEMED TOO OSTEOPOROTIC AND THIN FOR RESURFACING OR RELIABLE PRIMARY REPAIR. THE FRACTURE WAS REDUCED AND REINFORCED USING MESH EXTENSOR MECHANISM RECONSTRUCTION WITH MESH ALLOGRAFT FIXED INTO THE TIBIA. A 5-DEGREE, 9 MM DISTAL FEMORAL RESECTION WAS PERFORMED WITH AN INTRAMEDULLARY CUTTING GUIDE. POSTOPERATIVELY, ELIQUIS AND SCDS WERE ADMINISTERED FOR DVT PROPHYLAXIS, AND THE PATIENT WAS DISCHARGED TO OUTPATIENT REHABILITATION AFTER A TWO-DAY HOSPITAL STAY. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT IS CONFIRMED BASED ON THE MEDICAL RECORDS PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.