MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. 3DKNEE; INSERT, 3D SIZE6 X 11MM R DCM

Catalog Number	392-11-606
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060)
Date of Event	02/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Surgeon retained implant.
Event or Problem Description
Revision surgery - due to the patient presenting with idiopathic patello-femoral pain.The surgeon re-operated on the right knee through the traditional medial para-patellar incision, removed scar tissue surrounding the patella implant, released the patella laterally and replaced the polyethylene tibial bearing from a (392-11-606) size 6x11mm to a (392-13-706) size 6x13mm implant.He then closed in a traditional manner using sutures and staples.
Additional Manufacturer Narrative
The reason for this revision surgery was idiopathic patello-femoral pain.The previous surgery and the revision detailed in this investigation occurred 2 years and 10 months apart.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 retained by the surgeon and not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported components used in the previous surgery met design and manufacturing requirements.There was a non-conforming material report (b)(4) associated with the part 392-11-606, insert 3d size 6x11mm which documents a non-conformance that out of (b)(4) component lot 1 item with tool mark in cruciate notch was accepted with justification of "minor tool mark has no sharp edges, minimal apparent depth" and it has no impact on intended functionality of the tibial insert.The device was within the expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to the patello-femoral pain.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the event.There are multiple factors which may cause the event that are outside the control of djo surgical are patient weight, degenerative bone, patient activities, excessive range-of-motion, trauma and poor bone quality.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event and hence a definitive root cause cannot be determined.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: 3DKNEE
• Common Device Name: INSERT, 3D SIZE6 X 11MM R DCM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6437573
• Report Number: 1644408-2017-00178
• Device Sequence Number: 11009626
• Product Code: JWH
• UDI-Device Identifier: 00888912120449
• UDI-Public: (01)00888912120449
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K020114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 392-11-606
• Device Lot Number: 59601937
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2017
• Supplement Report FDA Received Date: 05/03/2017
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 90