MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY® TIBIAL TRAY SIZE 4; SMALL JOINT COMPONENT

Catalog Number 3365-0004

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

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 1043534-2016-00105, 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.

• Brand Name: INFINITY® TIBIAL TRAY SIZE 4
• 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 Key: 5967605
• MDR Text Key: 55322628
• Report Number: 1043534-2016-00104
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140749
• Number of Events Reported: 1
• 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

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 3365-0004
• Device Lot Number: 11554339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/30/2016
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR