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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.
 
Manufacturer Narrative
Section h10: (h3) the evaluation is pending.(d11) concomitant devices: ceramic head (sn# (b)(6).54 liner (cat# 130-36-52).Intergrip shell (cat# 180-01-54).No information provided in the following section(s): a5, b6, d4 (serial number, and exp date) and h4.The following section(s) have additional info; d4 (expire date and udi number), g4, g5, g7, h1, and h2.Section h11: corrections made in the following section(s): (d1) brand name.(d2) product code and common device name.(d4) catalog number and udi number.
 
Event Description
As reported, this 65 y/o male who weighed 169 lbs, was initially implanted with a left tha in (b)(6) 2018.A revision was scheduled due to the stem was loose.The cup was well fixed but the surgeon wanted to adjust the version a bit, so he pulled the shell as well.Patient was last known to be in stable condition following the event.Devices are not available for return per hospital policy.All available information has been received at this time.Ceramic head (sn# (b)(6).54 liner (cat# 130-36-52).Intergrip shell (cat# 180-01-54).
 
Manufacturer Narrative
The evaluation noted that the reason for the revision reported was likely the result of failure to obtain initial osseointegration between the bone and proximal femoral stem.This may have been a combination of surgical technique, patient rehabilitation, or other contributing factors; however, this cannot be confirmed as the device was not returned for evaluation and no other first-hand details were provided.(d11) concomitant devices: ceramic head (sn#(b)(4).54 liner (cat# 130-36-52) integrip shell (cat# 180-01-54) no information provided in the following section(s): a5, b6, d4 (serial number, and exp date) and h4.
 
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Brand Name
ALTEON
Type of Device
ALTEON HA STEM CLR STD SZ 7
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key9369155
MDR Text Key168183628
Report Number1038671-2019-00585
Device Sequence Number1
Product Code MEH
UDI-Device Identifier10885862037022
UDI-Public10885862037022
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,Followup
Report Date 04/15/2020
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 Expiration Date03/14/2023
Device Model Number180-01-54
Device Catalogue Number190-30-07
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/13/2019
Initial Date FDA Received11/25/2019
Supplement Dates Manufacturer Received03/10/2020
03/25/2020
Supplement Dates FDA Received03/18/2020
04/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient Weight77
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