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Exactech 100-26-05Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862009630), received between Feb 16, 2023 and Feb 16, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Component Incompatible” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Component Incompatible1
  • Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 16, 2023Component Incompatible; Loosening of Implant Not Related to Bone-Ingrowth; Component Incompatible; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED, A 70 YO MALE PATIENT, WHO HAD A RIGHT HIP REVISION PROCEDURE IN 2001, AND WAS IMPLANTED WITH AN ACCUMATCH M-SERIES STEM WITH AN OMNIFIT DUAL GEOMETRY CUP, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 22 YEARS POST THE INITIAL PROCEDURE DUE TO A LOOSE CUP AND OSTEOLYSIS. DURING BOOKING THE PROCEDURE, THE INFORMATION UNDERSTOOD, WAS AN EXACTECH STEM AND A 26MM +5 HEAD WAS IN SITU. THE ACETABULAR SIDE WAS ORIGINALLY A COMPETITOR OMNIFIT DUAL GEOMETRY CUP, THAT WAS REVISED TO ANOTHER COMPETITOR TRABECULAR METAL REVISION CUP, TM AUGMENTS AND A CEMENTED AVANTAGE DUAL MOBILITY CUP. THE STEM NEEDED A 28MM HEAD TO CONFORM WITH THE AVANTAGE POLY DM LINER. INFORMATION COMMUNICATED WAS THAT THIS STEM TAPER IS 12/14 AND THE ONLY HEADS THAT ARE AVAILABLE REFLECT THIS TAPER. 22,28,32 & 36MM HEAD TRIALS AND IMPLANTS WERE PROVIDED FOR THE CASE. ONCE THE ACETABULAR REVISION HAD BEEN PERFORMED, DURING TRIAL REDUCTION, THE 12/14 28MM +7 HEAD TRIAL WITH THE RELEVANT OFFSET AND LEG LENGTH SEEMED ACCURATE. HOWEVER, ONCE THE DEFINITIVE IMPLANT WAS OPENED IT DID NOT FIT THE TAPER OF THE STEM. IT WAS TOO LARGE. THE STEM TAPER WAS OBVIOUSLY SMALLER THAN THE APERTURE OF THE HE

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 16393506 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.