Fusion Cups FC10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842188100734), received between Dec 15, 2022 and Dec 22, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Crack; Material Integrity Problem; Crack; Material Integrity Problem

  SALES REP REPORTED ON 26NOV2025 THAT A FC10 HAD TO BE REMOVED FROM A PATIENT DUE TO A NON-UNION. AFTER THE DEVICE WAS REMOVED, IT WAS DISCOVERED THAT THE FC10 WAS CRACKED/BROKEN. THE DEVICE AND THE REPS' FIELD FEEDBACK FORM WAS MAILED TO TRIMED AND RECEIVED ON 11DEC2025 WHICH IS WHEN THE INFORMATION ABOUT THE RETURN WAS FORWARDED TO THE QUALITY DEPARTMENT. QUALITY FOLLOWED UP WITH THE REP ON 11DEC2025 WHICH THE REP PROVIDED ADDITIONAL INFORMATION ON 15DEC2025. THE REP STATED THAT THEY ARE NOT SURE WHEN THE DEVICE WAS ORIGINALLY IMPLANTED, HE ASSUMES THE DISCOMFORT WAS RELATED TO THE FACT THAT THIS WAS A NON-UNION, HE DOES NOT KNOW WHAT WAS USED TO REPLACE THE DEVICE AND HE DOES NOT KNOW WHAT CAUSED THE NON-UNION. PATIENT RELATED INFORMATION IS UNKNOWN. THE REMOVAL SURGERY WAS SUCCESSFUL BUT THERE WERE NO X-RAYS PROVIDED.

  Patient problems: Implant Pain

  MAUDE report 23865591 ↗
• InjuryJun 14, 2023Fracture; Fracture

  THE SURGEON STATE THAT THE POSITION OF THE PLATE WAS NOT IDEAL THAT COULD HAVE CAUSED THE DELAYED UNION WHICH WOULD HAVE LEAD TO FATIGUE OF THE PLATE. THE SURGEON STATED THAT IT WAS BELIEVED THAT THE POSITION OF THE PLATE WAS THE PRIMARY PROBLEM OF THE PATIENT DISCOMFORT, RATHER THAN MATERIAL FAILURE.

  Patient problems: Implant Pain

  MAUDE report 17131897 ↗
• MalfunctionDec 15, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  (B)(6) REPORTED ON (B)(6)2022 THAT HE WOULD LIKE TO RETURN A FC10 MARKED WITH "DO NOT IMPLANT" ON IT. IT WAS REPORTED THAT THIS ITEM DID NOT COME IN CONTACT WITH A PATIENT AND DID NOT CAUSE ADDITIONAL HARM. THE ITEM IS AVAILABLE TO BE RETURNED. PICTURES ARE AVAILABLE.

  Patient problems: Arthritis; Rheumatoid Arthritis

  MAUDE report 15993139 ↗