MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALL POLY KNEE; DOMED TRI-PEG PATELLA, 35X9MM, E-PLUS

Model Number	130-03-735
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/26/2019
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 - due to patella pain.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was due to patella pain.The previous surgery and the surgery detailed in this event occurred 1 year 4 months apart.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The healthcare professional indicated there was no delay in surgery and another suitable device was available.The revision surgery was completed as intended and without incident.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports (ncmr) associated with the product that may have contributed to the reported event.The devices were 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 pain.There were no findings during this evaluation that indicate that the reported devices were defective.The surgeon performed this procedure to remedy the patient's condition.There are multiple factors that may contribute to an event that are outside of the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, excessive range of motion, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.
Additional Manufacturer Narrative
D10 adding concomitant part 600-15-100.

• Brand Name: ALL POLY KNEE
• Common Device Name: DOMED TRI-PEG PATELLA, 35X9MM, E-PLUS
• 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: teffany hutto ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9511003
• Report Number: 1644408-2019-01265
• Device Sequence Number: 2080694
• Product Code: OIY
• UDI-Device Identifier: 00888912108553
• UDI-Public: (01)00888912108553
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2022

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: 07/26/2022
• Device Model Number: 130-03-735
• Device Catalogue Number: 130-03-735
• Device Lot Number: 156N1248
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 12/23/2019; 12/23/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 01/28/2020; 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2017
• 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: 600-15-100 COBALT G-HV BONE CEMENT 40GM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female