MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION KNEE; INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE6 15MM CM

Model Number	360-15-506
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - patient presented with posterior subluxation and knee had a grinding noise during flexion.The post on the ps poly had snapped off and had to be replaced.A size 19mm was also implanted instead of a 15mm to achieve greater stability.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as posterior subluxation.The previous surgery and the surgery detailed in this event occurred 5 years 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 the 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 non conformance associated with the main part #360-15-506, insert, posterior stabilized, series 500, size6 15mm cm which documents that out of 8 parts lot 1 part was rejected and scrapped due to dimension out of tolerance.All other items in the lot was 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 posterior subluxation.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.

• Brand Name: FOUNDATION KNEE
• Common Device Name: INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE6 15MM CM
• 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: kiersten soderman ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 13079041
• Report Number: 1644408-2021-01477
• Device Sequence Number: 4153796
• Product Code: JWH
• UDI-Device Identifier: 00888912116480
• UDI-Public: (01)00888912116480
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2021

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: 04/30/2020
• Device Model Number: 360-15-506
• Device Catalogue Number: 360-15-506
• Device Lot Number: 363B1022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male