MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. 3DKNEE; INSERT, 3D EX SZ 7RT 9MM

Catalog Number	392-09-707
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/09/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient becoming unstable after a fall.
Additional Manufacturer Narrative
The reason for this revision surgery was instability.The length of in vivo service was10.4 months.The healthcare professional indicated there was a significant adverse event 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 (b)(4) for examination.A review of the device history records showed no non-conforming material reports associated with this product.A review of the product complaint report history showed there have been 5 prior complaints reported against this part number; summary of investigations: 1 trauma, 1 pain, 3 looseness.This is the first complaint against this lot number.The root cause of the knee instability was reported as a fall.The surgeon reported no issues associated with the explanted product.No other conditions relating to this event could be determined with confidence.This investigation produced no indications or suggestions of a product or process issue affecting implant safety or effectiveness.

• Brand Name: 3DKNEE
• Common Device Name: INSERT, 3D EX SZ 7RT 9MM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 5353928
• Report Number: 1644408-2015-00770
• Device Sequence Number: 988143
• Product Code: OIY
• UDI-Device Identifier: 00888912120272
• UDI-Public: (01)00888912120272
• 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: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Followup
• Report Date (Section B): 12/09/2015

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: 05/31/2019
• Device Catalogue Number: 392-09-707
• Device Lot Number: 59604855
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2016
• Supplement Report FDA Received Date: 05/16/2016
• 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: 56 YR