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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. ALTEON ALTEON HA STEM CLR STD SZ 7

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EXACTECH, INC. ALTEON ALTEON HA STEM CLR STD SZ 7 Back to Search Results
Model Number 180-01-54
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 11/13/2019
Event Type  Injury  
Manufacturer Narrative
Pending evaluation. Concomitant device(s): ceramic head (cn: unk, sn# (b)(4)), 54 liner (cn: 130-36-52, sn: unk), alteon ha stem sz 7 (cn: 190-30-07 / sn# (b)(4)).
 
Event Description
Revision of the left tha because the stem was loose. The cup was well fixed but he wanted to adjust the version a bit, so he pulled the shell as well. The index surgery date was (b)(6) of 2018, however i did not have a date.
 
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Brand NameALTEON
Type of DeviceALTEON HA STEM CLR STD SZ 7
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
kate jacobson
3523782617
MDR Report Key9369155
MDR Text Key168183628
Report Number1038671-2019-00585
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162732
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number180-01-54
Device Catalogue Number190-30-07
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/25/2019 Patient Sequence Number: 1
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