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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 4

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EXACTECH, INC. ALTEON ALT HA S CLR STD SZ 4 Back to Search Results
Model Number 190-30-04
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 09/10/2020
Event Type  Injury  
Manufacturer Narrative
Pending evaluation. Concomitant medical products: (cn: 170-32-07, sn: (b)(4)) 36+7 biolox 12/14 head; (cn: 130-32-51, sn: (b)(4)) g1 novation neutral liner.
 
Event Description
As reported, approximately 34 months postop the initial left tha, this (b)(6) y/o female patient¿s left hip stem was revised due to loosening. The head was removed and the poly for the cup was removed to check if the cup was well fixed. A new novation liner was implanted and the patient receives an exactech monobloc stem. Patient was last known to be in stable condition following the event. Devices to be returned. Rg pending.
 
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Brand NameALTEON
Type of DeviceALT HA S CLR STD SZ 4
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 Key10676971
MDR Text Key211247683
Report Number1038671-2020-00570
Device Sequence Number1
Product Code MEH
UDI-Device Identifier10885862321060
UDI-Public10885862321060
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
Report Date 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/05/2022
Device Model Number190-30-04
Device Catalogue Number190-30-04
Device Lot Number85357002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2017
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: 10/14/2020 Patient Sequence Number: 1
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