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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. SHOULDER COMPONENTS; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
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EXACTECH, INC. SHOULDER COMPONENTS; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 04/02/2024
Event Type  Injury  
Manufacturer Narrative
Section h10: (h3) pending evaluation.
 
Event Description
It was reported that this female patient's left shoulder was revised approximately 3 years post op.The patient was doing great at 1 year with a oss of 46/48 but then rapidly deteriorated over the course of the next 18 months.It's not clear why.Her x-ray showed cuff failure and lucency around the glenoid and humerus.During the case yesterday it didn't look grossly infected, and the cuff was intact.Both components were loose - email from the surgeon.Patient was last known to be in stable condition following the event.Product not returning - hospital policy.
 
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Brand Name
SHOULDER COMPONENTS
Type of Device
PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH
2320 nw 66th court
gainesville FL 32653
Manufacturer Contact
matt collins
2320 nw 66th court
gainesville, FL 32653
3523771140
MDR Report Key19162254
MDR Text Key340796400
Report Number1038671-2024-00943
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/03/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNK.
Patient SexFemale
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