MAUDE Adverse Event Report: ENCORE MEDICAL L.P DOMED TRI-PEG PATELLA, 35X9MM, E-PLUS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER

Model Number 130-03-735

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Date 05/09/2023

Event Type  Injury  

Event Description

Revision surgery - due to loosening.

Manufacturer Narrative

The reason for this revision surgery, the agent reported "(loosening patella)".The previous surgery and the surgery detailed in this event occurred 3 years and 6 months apart.This evaluation is limited in scope as the item associated with this investigation was not returned to djo surgical - austin for review.The surgery was completed as intended and without incident.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There were no findings during this evaluation that indicate the reported device was defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.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 associated with the main part #130-03-735, domed tri peg patella, 35x9mm, eplus which documents that out of 20 parts lot, 1 part was rejected and scrapped due to surface finish was not to print.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 loosening.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 or patient activities.

• Brand Name: DOMED TRI-PEG PATELLA, 35X9MM, E-PLUS
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 17066707
• MDR Text Key: 316570026
• Report Number: 1644408-2023-00680
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00888912108553
• UDI-Public: 00888912108553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113756
• 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: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 130-03-735
• Device Catalogue Number: 130-03-735
• Device Lot Number: 156N1529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• 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: 55 YR
• Patient Sex: Female