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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL CONST LINER +2.5

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EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL CONST LINER +2.5 Back to Search Results
Catalog Number 320-38-13
Device Problem Microbial Contamination of Device (2303)
Patient Problems Unspecified Infection (1930); Pain (1994)
Event Date 11/27/2018
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Dr.(b)(6) revised a shoulder that was infected and the patient was complaining of pain.The patient's health was stable as they left the o.R.
 
Manufacturer Narrative
The revision reported was likely the result of infection, which led to pain.
 
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Brand Name
EQUINOXE REVERSE 38MM HUMERAL CONST LINER +2.5
Type of Device
LINER
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
Manufacturer Contact
graham cuthbert
2320 nw 66th court
gainesville, FL 32653
3523771140
MDR Report Key8120602
MDR Text Key128917042
Report Number1038671-2018-00909
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number320-38-13
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/28/2018
Initial Date FDA Received11/30/2018
Supplement Dates Manufacturer Received11/28/2018
Supplement Dates FDA Received01/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient Weight128
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