MAUDE Adverse Event Report: ENCORE MEDICAL L.P. HIGHLY CROSS-LINKED TIBIAL INSERT; INSERT, 3D EX SZ 7LT 9MM

Model Number	391-09-707
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to knee pain.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was due to patient having knee pain.The previous surgery and the surgery detailed in this event occurred 4.1 years apart.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.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 disposed of at the hospital and not made available to djo surgical for examination.A review of the device history record show that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to due to replace the shell.There were no findings during this evaluation that indicate that the reported device was defective.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: HIGHLY CROSS-LINKED TIBIAL INSERT
• Common Device Name: INSERT, 3D EX SZ 7LT 9MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 9490691
• Report Number: 1644408-2019-01250
• Device Sequence Number: 14198482
• Product Code: OIY
• UDI-Device Identifier: 00888912118972
• UDI-Public: (01)00888912118972
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2020

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: 08/31/2019
• Device Model Number: 391-09-707
• Device Catalogue Number: 391-09-707
• Device Lot Number: 59605201
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/19/2020
• 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: 236-01-107, LOT 950A1022; 336-01-108, LOT 313B1002
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR