MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EPIK UNI KNEE; BASEPLATE, ONLAY TIBIA, SIZE35 LM/RL EPIK

Model Number	300-01-035
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	02/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient experiencing pain and swelling.There was no diagnosis of an existing disease.The surgeon had simply stated that it may be the onset of a disease but there was no clinical evidence suggesting that this was a fact.
Additional Manufacturer Narrative
The reason for this revision surgery was due to the swelling and pain.The previous surgery and the revision detailed in this investigation occurred 2.1 years apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.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 disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) shows a non-conforming material report (ncmr) # 23398 associated with the part 300-01-035, epik baseplate, size 35 which documents a nonconformance that out of 10 quantity lot 8 items were rejected due to out of tolerance in dimension.In that 2 items were scrapped and remaining 6 items were accepted with the justification of undersize condition of casting does not create a sharp edge.All items in the lot met the fit, design and functional requirements.The device was within its 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 swelling and 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 many factors that may contribute to the event that are outside the control of djo surgical such as: infection, degenerated cartilage, patient activities, degenerative disease or trauma.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
Additional Manufacturer Narrative
Additional narrative: concomitant medical products.Additional concomitant items needed to be added to the mdr complaint.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: EPIK UNI KNEE
• Common Device Name: BASEPLATE, ONLAY TIBIA, SIZE35 LM/RL EPIK
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7293779
• Report Number: 1644408-2018-00155
• Device Sequence Number: 1212287
• Product Code: HRY
• UDI-Device Identifier: 00888912113281
• UDI-Public: (01)00888912113281
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K022437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2021

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: 06/30/2020
• Device Model Number: 300-01-035
• Device Catalogue Number: 300-01-035
• Device Lot Number: 064B1009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 03/09/2018; 03/09/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 03/09/2018; 02/17/2021
• 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: 200-01-104, LOT 074A1018; 340-35-009, LOT 322B1018; 402439 LOT 508250; 200-01-104, LOT 074A1018; 340-35-009, LOT 322B1018
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR