MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION KNEE; INSERT, STD., PRIMARY, SIZE6 9MM

Model Number	385-09-506
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Synovitis (2094)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Additional 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 - patient had pain and stiffness in the left knee.Infection was checked via aspiration.Poly ethylene exchange was determined as best course of action.Surgery was initially done, poly debris most likely causing synovitis.In surgery, synovitis found.Poly ethlene and patella replaced.
Additional Manufacturer Narrative
Corrected data: see d.1., d.4.& d.10.Manufacturer narrative: the reason for this revision surgery was reported as synovitis (inflammation (swelling, pain, and warmth) of a synovial membrane) and possible infection.The previous surgery and the surgery detailed in this event occurred 18.7 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 devices were disposed of at hospital and not made available to djo surgical for examination.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.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 synovitis (inflammation (swelling, pain, and warmth of a synovial membrane) and possible infection.There were no findings during this evaluation that indicate the reported device was the source of the synovitis or had a direct connection with the patient's infection.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 caused the synovitis or contributed to the possible infection or inhibited the patient's immune system.There are multiple factors that may also contribute to an infection 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: FOUNDATION KNEE
• Common Device Name: INSERT, STD., PRIMARY, SIZE6 9MM
• 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: 13534224
• Report Number: 1644408-2022-00201
• Device Sequence Number: 20093291
• Product Code: JWH
• UDI-Device Identifier: 00888912117746
• UDI-Public: (01)00888912117746
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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: 11/28/2007
• Device Model Number: 385-09-506
• Device Catalogue Number: 385-09-506
• Device Lot Number: 763471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2002
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 120-01-032 LOT 874261; 120-01-738 LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male