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

Model Number 130-03-735

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 10/30/2017

Event Type  Injury  

Event Description

Revision surgery - due to the patella being loose.The surgeon removed it and the bone was prepped again.A new patella was cemented in.

Manufacturer Narrative

The reason for this revision surgery was due to loosening.The previous surgery and the revision detailed in this investigation occurred 1 year and 3 months apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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 implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event.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 loosening.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the event.There are many factors that may contribute to the event that are outside the control of djo surgical such as: loose joints from inadequate soft tissue support, degenerative bone, patient bone deterioration, weak thigh muscles, patient activities or trauma.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: HIGHLY CROSS LINKED KNEE
• Type of Device: 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: 7029427
• MDR Text Key: 91952708
• Report Number: 1644408-2017-01031
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00888912108553
• UDI-Public: (01)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: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2021
• Device Model Number: 130-03-735
• Device Catalogue Number: 130-03-735
• Device Lot Number: 156N1110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2016
• 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: 52 YR