MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3DKNEE; INSERT, 3D EX SZ 4RT 9MM

Catalog Number 392-09-704

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 04/03/2017

Event Type  Injury  

Event Description

Revision surgery - due to the patient being unstable.

Manufacturer Narrative

The reason for this revision surgery was instability.The actual length of in-vivo patient service for this product is unknown as the original surgery date was not provided or could be established.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.The healthcare professional indicated 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 (b)(4) for examination.A review of the device history record (dhr) was not conducted since a lot number was not provided or determined during the complaint evaluation.A search of the device investigation produced no anomalies or evidence of a product issue.Multiple searches of the (b)(4) records and patient database revealed no additional information concerning this event.The part number is unconfirmed.This complaint will be closed with the lot unknown pending receipt of additional information.Should additional information become available concerning this complaint, the complaint will be re-opened and a further review shall be conducted.This complaint is deemed to be non-product related.The complaint states the patient was unstable; the root cause for the instability was not reported.No other conditions relating to this event could be determined with confidence.The surgeon reported no issues associated with the explanted product.The complaint investigation is limited in scope since the part associated with this investigation was not returned to (b)(4) for evaluation.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: 3DKNEE
• Type of Device: INSERT, 3D EX SZ 4RT 9MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445
• MDR Report Key: 6579800
• MDR Text Key: 75593466
• Report Number: 1644408-2017-00473
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00888912120241
• UDI-Public: (01)00888912120241
• 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: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 392-09-704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention