MAUDE Adverse Event Report: ENCORE MEDICAL L. P. LATERAL PIVOT INSERT KNEE; INSERT, STD., PRIMARY, SIZE8 15MM CM

Model Number	385-15-508
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 the primary knee was implanted in texas over 10 years ago.The surgeon chose to do the revision surgery due to instability and so the poly was swapped.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was reported as instability.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or couldn't 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 device was disposed of at the hospital and not made available to djo surgical for examination.Given the limited information, a search for an invoice (of the previous surgery) produced no results, therefore the item removed could not be identified.Customer complaint history of the reported items 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 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.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: LATERAL PIVOT INSERT KNEE
• Common Device Name: INSERT, STD., PRIMARY, SIZE8 15MM CM
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 10766163
• Report Number: 1644408-2020-01064
• Device Sequence Number: 19111032
• Product Code: JWH
• UDI-Device Identifier: 00888912118002
• UDI-Public: (01)00888912118002
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K000590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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 Model Number: 385-15-508
• Device Catalogue Number: 385-15-508
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR