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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. INSERT TIBIA LOGIC PS SZ3 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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EXACTECH, INC. INSERT TIBIA LOGIC PS SZ3 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 02-012-35-3013
Device Problem Degraded (1153)
Patient Problem Failure of Implant (1924)
Event Date 10/21/2019
Event Type  Injury  
Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
 
Event Description
On (b)(6) 2010, a (b)(6) y/o, male patient with a bmi of 33.7, underwent implantation of a insert tibia logic ps sz3 13mm.On (b)(6) 2019, approximately 111 months post implant, the patient underwent revision due to polyethylene wear.
 
Manufacturer Narrative
After further review of additional information received the following sections d4, g3, g4, g5, g7, h2 and h3 have been updated accordingly.(h3) the evaluation noted that revision reported was likely the result of prosthesis wear which may have been due to the alignment between the femoral and tibial components, third body wear, and/or patient-related factors.However, this cannot be confirmed as the devices were not returned for evaluation.
 
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Brand Name
INSERT TIBIA LOGIC PS SZ3 13MM
Type of Device
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key10397049
MDR Text Key202586253
Report Number1038671-2020-00468
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
PMA/PMN Number
K033883
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number02-012-35-3013
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age63 YR
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