MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR 3D KNEE; EMPOWR 3D KNEETM INS, 10R 10MM, VE

Model Number	241-02-110
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient having instability.
Additional Manufacturer Narrative
The reason for this revision surgery was instability.The previous surgery and the revision detailed in this investigation occurred over 2 years and 3 weeks apart.There was no information submitted with this complaint about any patient activities, accidents or medical contraindications that may have contributed to the event.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 instability.There are multiple factors that may contribute to the event that are outside the control of djo surgical are poor bone density, inadequate soft tissue support, patient bone deterioration, patient activities or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient that may have contributed to the event and hence a definitive root cause cannot be determined.There were no findings during this investigation that indicate that the reported device (s) was the source or had a direct connection with the event.There are no indications of a product or process issue affecting implant safety or effectiveness.
Additional Manufacturer Narrative
Corrected data: common device name, concomitant medical products, and device manufacture date.

• Brand Name: EMPOWR 3D KNEE
• Common Device Name: EMPOWR 3D KNEETM INS, 10R 10MM, VE
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8254544
• Report Number: 1644408-2019-00024
• Device Sequence Number: 2154050
• Product Code: JWH
• UDI-Device Identifier: 00888912166775
• UDI-Public: (01)00888912166775
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K143242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2019

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: 10/28/2020
• Device Model Number: 241-02-110
• Device Catalogue Number: 342-10-710
• Device Lot Number: 080T1004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 01/16/2019; 01/16/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 01/16/2019; 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 130-03-735, LOT 156N1148; 130-03-735, LOT 156N1148; 241-02-110, LOT 954R1008; 342-10-710, LOT 080T1004; 351-04-110, LOT 037T1011; 351-04-110, LOT 037T1011
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR