MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EPIK KNEE; BASEPLATE, ONLAY TIBIA, SIZE37 RM/LL EPIK

Model Number 300-02-037

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Date 11/23/2022

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as instability and abnormal wear.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.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 devices were disposed of at hospital and not made available to djo surgical for examination.A review of the device history record (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There was no non-conforming material report (ncmr) 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.Item: unk-surg.The part and lot number was not reported, therefore; this component could not be linked to a specific device history record (dhr).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 instability and abnormal wear.The findings did not lead to a firm conclusion since the needed records were not made available at the time of this investigation.No 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.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

Event Description

Revision surgery - due to instability.After the implants were extracted from the patient, the tibial insert showed possible abnormal wear.

• Brand Name: EPIK KNEE
• Type of Device: BASEPLATE, ONLAY TIBIA, SIZE37 RM/LL EPIK
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 15934193
• MDR Text Key: 305009066
• Report Number: 1644408-2022-01635
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00888912113359
• UDI-Public: (01)00888912113359
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Model Number: 300-02-037
• Device Catalogue Number: 300-02-037
• Device Lot Number: 076B1009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK-SURG LOT UNKNOWN
• Patient Outcome(s): Required Intervention