MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR 3D KNEE; EMPOWR 3D KNEETM INS, 11L 12MM, VE

Model Number	341-12-711
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Primary surgery - wrong insert packaged in wrong box.(16mm insert) a left, size 11, 12mm empowr 3d knee insert package was opened and a left, size 11, 16mm empowr 3d knee insert was inside.The surgeon continued with the trialing process and ended up implanting a size 11, 14mm empowr 3d knee insert.
Additional Manufacturer Narrative
The reason for this complaint was a primary surgery reported as product lots being mixed during cleanroom processing.The healthcare professional indicated that this event occurred during surgery, away from the patient.No risk, adverse event, or negative outcome were reported by the surgeon.There was no delay in surgery and the surgery was completed as intended.The implants were inspected prior to use and were deemed acceptable for use.The agent was present during surgery and was able to source replacement implants after the reported defect.The reported empowr insert was returned to djo for examination.The defect was confirmed.A review of the device history record (dhr) revealed that work order (b)(4) was processed within the cleanroom sterilization process at the same time as work order (b)(4) for pn 341-16-711 lot number 155t1035.Upon completion of sterilization and were placed within the incorrect transportation bin.Reference (b)(4) for further details on investigation.A review of the device history records (dhr) revealed, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production that are related to the reported issue.Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review.The root cause of this complaint was product lots being mixed during cleanroom processing.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: EMPOWR 3D KNEE
• Common Device Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 11829531
• Report Number: 1644408-2021-00384
• Device Sequence Number: 4308443
• Product Code: JWH
• UDI-Device Identifier: 00888912166980
• UDI-Public: (01)00888912166980
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 12/22/2025
• Device Model Number: 341-12-711
• Device Catalogue Number: 341-12-711
• Device Lot Number: 115T1035
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 10/05/2021
• 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: Other