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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. PS TIBIAL BEARING, SIZE 3, 14MM, VIT E PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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ARTHREX, INC. PS TIBIAL BEARING, SIZE 3, 14MM, VIT E PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Model Number IBAL TKA,BEARING IMP,PS,SZ 3,18MM
Device Problems Bearings (734); Loose or Intermittent Connection (1371); Unstable Capture Threshold (3269)
Patient Problem Failure of Implant (1924)
Event Date 09/16/2019
Event Type  Injury  
Manufacturer Narrative

Complaint confirmed. The returned implant showed signs of wear on the posterior side, inferior and superior surfaces, as well as damage to the locking mechanism on the posterior side. The visible damage suggests the most likely cause of failure is a posterior to anterior event with a force greater than or equal to what would typically cause the tibial bearing to fail.

 
Event Description

It was reported that a patient had a total knee procedure on (b)(6) 2018. Roughly one and a half years after implantation the ar-523-b314 (lot: 115571546) tibial bearing came loose from the tibial tray, and the knee became unstable. The following arthrex parts were used during the primary procedure: ar-523-b314 // lot: 115571546 // qty. : 1. Ar-524-psc9 // lot: 132581730 // qty. : 1. Ar-513-t3 // lot: 10167303 // qty. : 1. Ar-516-5r // lot: 10183110 // qty. : 1. A bearing exchange procedure took place on (b)(6) 2019. During the revision procedure the surgeon explanted the ar-523-b314 (lot: 115571546), and implanted ar-513-bd18 (lot: 113601819). The rep reported the poly was the only arthrex device explanted during the revision procedure. The primary right tka and the bearing exchange procedure were performed by the same surgeon. The explanted device has been returned to arthrex.

 
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Brand NamePS TIBIAL BEARING, SIZE 3, 14MM, VIT E
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key9214786
MDR Text Key163360073
Report Number1220246-2019-01366
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK153586
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 10/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/21/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberIBAL TKA,BEARING IMP,PS,SZ 3,18MM
Device Catalogue NumberAR-523-B314
Device LOT Number113601819
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/25/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/21/2019 Patient Sequence Number: 1
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