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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. ALTEON ALT HA S CLR STD SZ 8

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EXACTECH, INC. ALTEON ALT HA S CLR STD SZ 8 Back to Search Results
Model Number 190-30-08
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 12/03/2020
Event Type  Injury  
Manufacturer Narrative
Pending evaluation. Concomitant device: novation ehxl natural liner g3 36mm; (cn: 140-36-53, sn: (b)(4)). Alteon ha stem collared standard size 8 (cn: 190-30-08, sn: (b)(4)). Biolox delta femoral head 36mm od, +0mm (cn: 170-36-00, sn: (b)(4)).
 
Event Description
As reported, approximately 11 months postop the initial left tha. This (b)(6) y/o male with a history of osteoarthritis, was revised. The patient received a new xle 40mm lipped liner, a 19x245 monobloc and a 40mm +10 head. Devices not returning. The patient requested the implants. Patient was last known to be in stable condition following the event.
 
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Brand NameALTEON
Type of DeviceALT HA S CLR STD SZ 8
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 Key11060999
MDR Text Key224059061
Report Number1038671-2020-00663
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number190-30-08
Device Catalogue Number190-30-08
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 Received12/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/22/2020 Patient Sequence Number: 1
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