MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3DKNEE; INSERT, 3D EX SZ 6LT 9MM

Model Number	391-09-706
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to an infection.Implants were removed and an antibiotic spacer was put in.Infection occurred caused by dental problems.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was a 2nd stage surgery to remove an antibiotic construct, used to alleviate a previous infection, and implant new components.Stage one consists of the removal of implants that are present in the infected joint, building a spacer to fill the joint and coating the spacer with antibiotics which is then implanted into the affected joint.The first stage surgery removed the parts listed in this complaint.Upon determination that the infection is under control and the tissue is normalized, stage 2, the antibiotic construct is removed and new components are implanted.The previous surgery and the surgery detailed in this investigation occurred over 2.8 months apart.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.There was no new information from the previous surgery regarding cultures identified in the infection, severity of the infection.The root cause of this complaint is a 2nd stage surgery to remove an antibiotic construct, used to alleviate a previous infection and implant new components.Said infection was reported to have been caused by dental problems.This event is not the result of a product deficiency, failure or issue.
Event or Problem Description
Revision surgery - the implants were removed and an antibiotic spacer was put in because an infection occurred caused by dental problems.This complaint is reporting the 2nd stage surgery to remove an antibiotic construct, used to alleviate the infection and implant new components.
Additional Manufacturer Narrative
Corrected data: the main component reported on this complaint was inadvertently reported.Manufacturer narrative; the root cause of this complaint is a 2nd stage surgery to remove an antibiotic construct, used to alleviate a previous infection, and implant new components.

• Brand Name: 3DKNEE
• Common Device Name: INSERT, 3D EX SZ 6LT 9MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8131047
• Report Number: 1644408-2018-01142
• Device Sequence Number: 11124951
• Product Code: OIY
• UDI-Device Identifier: 00888912118965
• UDI-Public: (01)00888912118965
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K091956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2019

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 Expiration Date: 11/28/2017
• Device Model Number: 391-09-706
• Device Catalogue Number: 391-09-706
• Device Lot Number: 59602754
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 01/21/2019; 02/06/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/28/2019; 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 233-01-106, LOT 890A1230; 333-01-106, LOT 271B1105
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR