MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EPIK KNEE; BASEPLATE, ONLAY TIBIA, SIZE45 RM/LL EPIK

Model Number	300-02-045
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2019
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 - conversion of total knee.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was due to patient needing to be converted to a total knee.The previous surgery and the surgery detailed in this event occurred 2 years and 1 months 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 surgery was completed as intended and without incident.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history record (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.Firstly there was a non conformance in main part#300-02-042, baseplate, onlay tibia, size45 rm/ll epik, which documents out of 8 parts lot 2 parts was rejected due to out of tolerance.All other items in the lot were met with fit, form and function.Secondly, there was another non conformance in concomitant part#340-45-009, insert, onlay tibial, epik, size45x9, which documents out of 10 parts lot 1 part was rejected due to out of tolerance.All other items in the lot were met with fit, form and function.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices 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 positioning of cup and liner was off.There were no findings during this evaluation that indicate the reported devices were defective.There are multiple factors that may contribute to an event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, excessive range of motion, patient activities or trauma.There were no indication of a product or process issue affecting implant safety or effectiveness.

• Brand Name: EPIK KNEE
• Common Device Name: BASEPLATE, ONLAY TIBIA, SIZE45 RM/LL EPIK
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9511004
• Report Number: 1644408-2019-01268
• Device Sequence Number: 2777434
• Product Code: HRY
• UDI-Device Identifier: 00888912113380
• UDI-Public: (01)00888912113380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 02/01/2020

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: 12/31/2020
• Device Model Number: 300-02-045
• Device Catalogue Number: 300-02-045
• Device Lot Number: 082B1006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/01/2020
• 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: 340-45-009 LOT 334B1038
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR