MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE; INSERT, 3D EX SZ 10RT 11MM

Model Number 392-11-710

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 02/24/2020

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Revision surgery - lysis due to back side wear.

Manufacturer Narrative

The reason for this revision surgery was reported as lysis due to back side wear.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.The healthcare professional indicated there was a significant adverse event to the patient.There was a delay of 45 minutes in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were disposed of at hospital and not made available to djo surgical for examination.This investigation is limited in scope as limited information was provided to djo surgical for review.The revised items were not returned for examination and the lot number was not provided.To adequately investigate this event, the lot numbers are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.This complaint will be closed pending receipt of additional information.

• Brand Name: 3D KNEE
• Type of Device: INSERT, 3D EX SZ 10RT 11MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 9878912
• MDR Text Key: 186137999
• Report Number: 1644408-2020-00256
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00888912120562
• UDI-Public: (01)00888912120562
• Combination Product (y/n): N
• PMA/PMN Number: K091956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 392-11-710
• Device Catalogue Number: 392-11-710
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR