UNKN JOURNEY KNEE IMPL
Received Aug 7, 2023 · Event occurred Jul 14, 2023
Report 1020279-2023-01563 · MDR key 17474955
Device
Generic name
Prosthesis, Knee, Hemi-, Femoral (uncemented)
Manufacturer
Smith & Nephew, Inc.Catalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Fracture
- Fracture
Patient
Unknown
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
SECTION H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, PER COMPLAINT DETAILS, A RIGHT TOTAL KNEE ARTHROPLASTY REVISION SURGERY WAS PERFORMED ABOUT 12-13 YEARS IMPLANTATION DUE TO A FRACTURED POLY POST. AS OF THE DATE OF THIS MEDICAL INVESTIGATION, THE REQUESTED CLINICAL DOCUMENTATION HAS NOT BEEN PROVIDED FOR EVALUATION. THEREFORE, THERE WERE NO CLINICAL FACTORS FOUND WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED POLY POST FRACTURE. THE PATIENT IMPACT BEYOND THE REVISION CANNOT BE DETERMINED. NO FURTHER MEDICAL ASSESSMENT CAN BE RENDERED AT THIS TIME. DEVICE SPECIFIC IDENTIFIERS WERE NOT PROVIDED. THEREFORE, AN EVALUATION OF THE MANUFACTURING RECORDS, COMPLAINT HISTORY REVIEW, INSTRUCTIONS FOR USE, RISK MANAGEMENT FILE, PRIOR ACTIONS AND PRODUCT PRINTS REVIEW COULD NOT BE PERFORMED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE ABNORMAL LOADING OF LIMB, EXCESSIVE FORCES AND/OR TRAUMATIC INJURY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.
Description of Event or Problem
IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY WAS PERFORMED AROUND (12) TWELVE-(13) THIRTEEN YEARS AGO THE PATIENT SUFFERED FROM A FRACTURE OF THE POLY POST AS A RESULT OF THIS ADVERSE EVENT, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, WHICH INVOLVED THE REMOVAL OF A 13MM 5/6 POLY POST AND INSTEAD A 15MM 5/6 INSERT WAS IMPLANTED. IN ADDITION, THE ORIGINAL SIZE WAS CHANGED DUE TO THE FACT THAT IT WAS LOOSE IN EXTENSION AND FLEXION, RESULTING IN THE NEED FOR A LARGER INSERT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Additional Manufacturer Narrative
INTERNAL COMPLAINT REFERENCE (B)(4).