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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; ALT HA S CLR EXT SZ 7
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EXACTECH, INC. ALTEON; ALT HA S CLR EXT SZ 7 Back to Search Results
Catalog Number 190-31-07
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 12/05/2019
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
As reported, the stem was loose proximally and was removed during a revision.The device is available for return to the manufacturer.
 
Manufacturer Narrative
(h3) the evaluation noted that the reason for the revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the femoral stem and pain.(d11) concomitant devices: (cn: 140-32-03, sn: (b)(6)) biolox femoral head 12/14, 32mm.
 
Event Description
As reported, the left stem was loose proximally 21 months after initial implantation and was removed during a revision.The patient was fairly active.The patient was reported to be doing well after the event.The device is available for return to the manufacturer.
 
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Brand Name
ALTEON
Type of Device
ALT HA S CLR EXT SZ 7
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key9512829
MDR Text Key173319738
Report Number1038671-2019-00618
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
PMA/PMN Number
K162732
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/28/2020
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 Number190-31-07
Device Lot Number80638050
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 12/05/2019
Initial Date FDA Received12/23/2019
Supplement Dates Manufacturer Received04/17/2020
Supplement Dates FDA Received04/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age61 YR
Patient Weight79
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