Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. SHOULDER COMPONENTS; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

EXACTECH, INC. SHOULDER COMPONENTS; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED Back to Search Results
Device Problem Naturally Worn (2988)
Patient Problem Failure of Implant (1924)
Event Date 04/08/2023
Event Type  Injury  
Manufacturer Narrative
H3: pending investigation.
 
Event Description
As reported, the patient had an initial right tsa on an unknown date.The patient was revised on (b)(6) 2023 to a competitor's devices due to poly wear.The preserve stem and cage glenoid were removed.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SHOULDER COMPONENTS
Type of Device
PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66th ct
gainesville FL 32653
Manufacturer Contact
michael crader
2320 nw 66th ct
gainesville, FL 32653
3523771140
MDR Report Key18651503
MDR Text Key334671800
Report Number1038671-2024-00163
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2024
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 Received01/18/2024
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
Patient Outcome(s) Required Intervention;
Patient SexMale
-
-