UNKNOWN TRICON M RECON KNEE IMPLANT
Received Oct 23, 2023 · Event occurred Nov 11, 2012
Report 1020279-2023-02022 · MDR key 17985729
Device
Generic name
Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cement
Manufacturer
Smith & Nephew, Inc.Catalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT ON LITERATURE REVIEW "CEMENTLESS FIXATION IN TOTAL KNEE ARTHROPLASTY", 3 PATIENTS HAD LATE SUPRACONDYLAR FRACTURES AFTER A TKA PROCEDURE USING TRICON M KNEE SYSTEM. THE EVENTS WERE RESOLVED BY REVISION SURGERY. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
H10: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF CLINICAL EVIDENCE FROM LITERATURE SOURCES THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED. DOI:10.1302/0301-620X.94B11. DREXLER, M., DWYER, T., MARMOR, M., ABOLGHASEMIAN, M., STERNHEIM, A., & CAMERON, H. U. (2012). CEMENTLESS FIXATION IN TOTAL KNEE ARTHROPLASTY: DOWN THE BOULEVARD OF BROKEN DREAMS¿OPPOSES. THE JOURNAL OF BONE & JOINT SURGERY BRITISH VOLUME, 94(11_SUPPLE_A), 85-89.