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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY POLY; SMALL JOINT COMPONENT

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WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY POLY; SMALL JOINT COMPONENT Back to Search Results
Catalog Number 3365-4307
Device Problem Device Slipped (1584)
Patient Problem No Information (3190)
Event Date 08/30/2016
Event Type  Injury  
Manufacturer Narrative
The investigation is not complete.Trends will be evaluated.This report will be updated when the investigation is complete.This is the same event as 1043534-2016-00104, 00106, 00107.
 
Event Description
Full revision of product: allegedly, all components were loose.
 
Manufacturer Narrative
Visual examination of the poly insert shows no deformation in the dove tail region to indicate that the insert was mal-aligned during insertion.There are a few gauge marks and the lock detail has split, which are consistent with removal during the revision surgery.Visual examination the porous surface of the talar dome and tibial tray/stem does exhibit a few areas of apparent bone attachment.There are some heavier scratches/dings on these devices that are consistent with removal.
 
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Brand Name
INFINITY POLY
Type of Device
SMALL JOINT COMPONENT
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
timothy nickel
1023 cherry road
memphis, TN 38117
901451-631
MDR Report Key5967702
MDR Text Key55322888
Report Number1043534-2016-00105
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140749
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/21/2016
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? Yes
Device Operator Other
Device Catalogue Number3365-4307
Device Lot Number1547475
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2016
Is the Reporter a Health Professional? No
Distributor Facility Aware Date08/30/2016
Initial Date Manufacturer Received 08/30/2016
Initial Date FDA Received09/21/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/24/2017
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age45 YR
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