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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SHOULDER COMPONENTS
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EXACTECH, INC. EQUINOXE; SHOULDER COMPONENTS Back to Search Results
Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Toxicity (2333)
Event Date 01/27/2020
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
As reported, a revision of a primary shoulder.The surgeon was concerned because it failed secondary to metallosis from the morse taper.The head was grossly loose as was the adapter with gross metal debris throughout.The surgeon thought it was just the glenoid, but once in there, it was impressively more on the humeral side.The devices will not be returned.
 
Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of aseptic (non-infected) loosening, which may have been secondary to metallosis from the taper between the humeral head and replicator plate.However, underlying cause of the metallosis cannot be confirmed as the devices were not available for evaluation and no further details were provided.(h6) evaluation codes: 1924, 4002.
 
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Brand Name
EQUINOXE
Type of Device
SHOULDER COMPONENTS
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key9711993
MDR Text Key190361805
Report Number1038671-2020-00179
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received08/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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