MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR PS KNEE; EMPOWR PS KNEETM TIBIAL INSERT, SIZE 9, 12MM

Model Number	343-12-709
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as fall.The previous surgery and the revision detailed in this investigation occurred over 44 days 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 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 (ncmr) 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 fall.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.Agent has clearly mentioned that the "patient fell and wound split open, did a wash out." it seems that the event might have possibly occurred due to lack of care, patient activities or trauma.Due to the short time between previous and revision surgery, it is also possible that the event may have been occurred due to improper implant selection, or patient non-compliance with medical instructions.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any patient 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.
Event or Problem Description
Revision surgery- patient fell and wound split open.So, did a wash out.

• Brand Name: EMPOWR PS KNEE
• Common Device Name: EMPOWR PS KNEETM TIBIAL INSERT, SIZE 9, 12MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 8952382
• Report Number: 1644408-2019-00815
• Device Sequence Number: 2521029
• Product Code: JWH
• UDI-Device Identifier: 00888912172257
• UDI-Public: (01)00888912172257
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

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: 06/15/2021
• Device Model Number: 343-12-709
• Device Catalogue Number: 343-12-709
• Device Lot Number: 024U1006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2019
• Initial Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR