MAUDE Adverse Event Report: ENCORE MEDICAL L.P. HXL VE E+ PATELLA; DOMED TRI-PEG PATELLA, 35X9MM, E-PLUS

Model Number 130-03-735

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

Patient Problem Pain (1994)

Event Date 05/07/2019

Event Type  Injury  

Event Description

Revision surgery - due to the patient having knee pain.

Manufacturer Narrative

The reason for this revision surgery was due to the knee pain.The previous surgery and the revision detailed in this investigation occurred over 1 year and 5 months 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 has not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There was a nonconformance associated with the part #130-03-735, domed tri-peg patella, 35x9mm, e-plus which documents that out of 20 quantities lot, 1 part was rejected and scrapped due to surface finish on area "a" is not similar to print.Remaining 19 parts in the lot met with design, fit and functional requirements.The device was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to the knee pain.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's event.There are multiple factors that may contribute to the event that are outside the control of djo surgical are soft tissue impingement, degenerative bone disease, excessive weight, patient's age, unbalanced joint or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.There are no indications of a product or process issue affecting implant safety or effectiveness.

Manufacturer Narrative

Additional information provided in d.10.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: HXL VE E+ PATELLA
• Type of Device: DOMED TRI-PEG PATELLA, 35X9MM, E-PLUS
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8677168
• MDR Text Key: 147304102
• Report Number: 1644408-2019-00510
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00888912108553
• UDI-Public: (01)00888912108553
• Combination Product (y/n): N
• PMA/PMN Number: K113756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2022
• Device Model Number: 130-03-735
• Device Catalogue Number: 130-03-735
• Device Lot Number: 156N1258
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 600-15-000, LOT 881500.
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR