MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. 3DKNEE; INSERT, 3D EX SZ 7RT 11MM

Catalog Number 392-11-707

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 12/19/2016

Event Type  Injury  

Event Description

Revision surgery - due to the patient falling and the surgeon deciding to replace the pattella and insert.

Manufacturer Narrative

The tendon tear was not reported in the initial medical device report.Concomitant medical products: 318-02-006, lot 145b1002 was reported on the initial medical device report, it should be 130-03-732,lot 155n1067.The reason for this revision surgery was a tendon tear.The in-vivo length of patient service for the implant was 1.4 years.The healthcare professional indicated there was a serious risk to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing of this part.All critical dimensions and specifications in effect at the time the part was manufactured were met.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed as non-product related.The root cause for the tendon tearing was reported as a fall.The scope of this investigation is limited without having the parts available to djo surgical for evaluation.Other conditions relating to this event could not be determined with confidence.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

Event Description

Revision surgery - due to the patient falling.The surgeon went in and it was a tendon tear; the surgeon decided to replace the patella and insert.

• Brand Name: 3DKNEE
• Type of Device: INSERT, 3D EX SZ 7RT 11MM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 6244352
• MDR Text Key: 64579844
• Report Number: 1644408-2016-01068
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00888912120548
• UDI-Public: (01)00888912120548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2017

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 Date: 09/20/2019
• Device Catalogue Number: 392-11-707
• Device Lot Number: 59605300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 318-02-006,LOT 145B1002
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 46 YR