MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR PS KNEE; EMPOWR PS KNEETM TIBIAL INSERT, SIZE 8, 13MM

Model Number	343-13-708
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint - there was a size 7x19 in a 8x13 box.
Additional Manufacturer Narrative
Manufacturer narrative: the part was returned on 1-sep-2017.The agent was present when the issue occurred near the patient; the device was examined before use and found to be acceptable.Another suitable device was available, and surgery was completed as intended with a 5 minute delay.The surgeon indicated a no risk or adverse event.Patient information was not reported but is not relevant to this event.The part listed as the main contributor in the complaint is part number 343-13-708, empowr posterior stabilized (ps) knee tibial insert, size 8, 13 millimeter, lot number 287u1004.The component that was inside the box is part number 343-19-707, empowr posterior stabilized (ps) knee tibial insert, size 7, 19 millimeter, lot number 066u1003.The returned part was received from the field confirming the complaint.A device history record (dhr) review was conducted.Part/lot number 343-13-708, 287u1004, quantity 50, manufacturing date: 22-jul-2016, expiration date: 05-jul-2021.It was observed that the two lots in question were processed by an outside contractor for packaging and sterilization on the (b)(6) 2016.These two lots were the only lots listed on the certificate of processing.In addition, remaining units of the incident lots in finished goods inventory were opened and found to have the same nonconformance.It is reasonable to believe that the full quantity of both lots may have been incorrectly boxed and labeled.In light of this information, a corrective action/preventive action (capa) and health hazard evaluation (hhe) will be opened to fully investigate this issue.Complaint history was reviewed.No other complaints were identified with the reported failure mode.

• Brand Name: EMPOWR PS KNEE
• Common Device Name: EMPOWR PS KNEETM TIBIAL INSERT, SIZE 8, 13MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 6899471
• Report Number: 1644408-2017-00831
• Device Sequence Number: 1354823
• Product Code: JWH
• UDI-Device Identifier: 00888912172363
• UDI-Public: (01)00888912172363
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 343-13-708
• Device Catalogue Number: 343-13-708
• Device Lot Number: 287U1004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 04/23/2018
• 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: 343-19-707; 343-19-707, LOT 055U1003