MAUDE Adverse Event Report: ENCORE MEDICAL LP 3D KNEE; INSERT, 3D EX SZ 8RT 9MM

Model Number 392-09-708

Device Problem Unstable (1667)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/26/2021

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as instability.The previous surgery and the surgery detailed in this event occurred 4 months apart.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 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 a nonconformance in main part #392-09-708, insert, 3d ex sz 8rt 9mm which documents that out of 20 parts lot, 2 parts were rejected and scrapped out of which 1 part was due to pulled out of fixture and the other was due to nick on the part.All other items in the lot were met with fit, form and function requirements.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 instability.There were no findings during this evaluation that indicate the reported device was defective.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 also contribute to an event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Revision surgery - due to instability.9mm liner was removed and replaced with a 6/11 insert.

• Brand Name: 3D KNEE
• Type of Device: INSERT, 3D EX SZ 8RT 9MM
• Manufacturer (Section D): ENCORE MEDICAL LP; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL LP; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 12281655
• MDR Text Key: 265221987
• Report Number: 1644408-2021-00801
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00888912120289
• UDI-Public: (01)00888912120289
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/05/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2023
• Device Model Number: 392-09-708
• Device Catalogue Number: 392-09-708
• Device Lot Number: 330G1115
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR