MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE; INSERT, 3D EX SZ 8RT 11MM

Model Number	392-11-708
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the poly being loose.
Additional Manufacturer Narrative
The reason for this revision surgery was due to a loose poly.The actual length of in-vivo for the item listed 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 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 (dhr) was not conducted since the item and or lot number(s) was not provided or determined during the complaint evaluation.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.Given the limited information, a search for an invoice of the previous surgery produced no results.Should additional information become available this investigation will be re-opened for further evaluation.The root cause of this complaint was a revision surgery due to loose poly.The surgeon performed this procedure to remedy the patient's condition.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: 3D KNEE
• Common Device Name: INSERT, 3D EX SZ 8RT 11MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8028793
• Report Number: 1644408-2018-00986
• Device Sequence Number: 1303272
• Product Code: OIY
• UDI-Device Identifier: 00888912120555
• UDI-Public: (01)00888912120555
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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
• Operator of Device: Health Professional
• Device Model Number: 392-11-708
• Device Catalogue Number: 392-11-708
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 50 YR