GII OXINIUM FEMORAL IMPACTOR
Received May 5, 2026 · Event occurred Apr 14, 2026
Report 1020279-2026-00615 · MDR key 25089359
Device
Generic name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Manufacturer
Smith & Nephew, Inc.Catalog number
71440890
Lot number
03KM11496
Product problems
- Break
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. THE VISUAL INSPECTION REVEALED THAT THE DEVICE RETURNED HEAVILY WORN FROM USE, WITH THE IMPACTOR HEAD FRACTURED OFF AND RETURNED WITH THE SHAFT. A REVIEW OF THE PRODUCTION ORDER DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY REVEALED SIMILAR EVENTS FOR THE LISTED PART NUMBER OVER THE PREVIOUS 12 MONTHS, BUT NO SIMILAR EVENTS FOR THE BATCH BASED ON THE HISTORICAL DATA, THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY POTENTIAL FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD 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, DURING A TKA SURGERY, ONE (1) GII OXINIUM FEMORAL IMPACTOR BROKE DURING FEMORAL IMPLANTATION. NOTHING FELL INTO THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
INTERNAL COMPLAINT REFERENCE: (B)(4).