MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR PARTIAL KNEE; EMPOWR PARTIAL KNEETM, TIBIAL INSERT, SIZE 6, 8MM

Model Number	347-08-706
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Complaint - surgeon went to put in the insert but it wasn't seated completely in the baseplate.Hospital discarded insert.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was reported as misalignment.This event occurred during surgery near the patient.There was another suitable device available, the incident did cause a 3 min.Delay in surgery, however, surgery was completed as intended, there was no risk or adverse event reported and the item was inspected prior to surgery and was found to be acceptable.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history record (dhr) shows that the reported device, when released for use, met design and manufacturing requirements.There was no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.Complaint database review showed no previous complaints against this device.This event is possibly attributable to misalignment which surgical devices are subjected to.Surgical items condition can be determined while being used for its intended purpose.The replacement of surgical items does not indicate a product deficiency, failure or issue.This is not an event associated with a product failure, malfunction or issue.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was reported as surgeon went to put in the insert but it wasn't seated completely in the baseplate.Surgeon was attempting to impact the final poly implant into the tibial baseplate but couldn't get the anterior aspect to fully seat/lock.It was good on the posterior side.Surgeon pulled out another poly which seated/locked fine.This event occurred during surgery near the patient.There was another suitable device available, the incident did cause a 3 minute delay in surgery, however, surgery was completed as intended, there was no risk or adverse event reported and the item was inspected prior to surgery and was found to be acceptable.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history record (dhr) shows that the reported device, when released for use, met design and manufacturing requirements.There was no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.Complaint database review showed no previous complaints against this device.This event is possibly attributable to misalignment which surgical devices are subjected to.Surgical items condition can be determined while being used for its intended purpose.The replacement of surgical items does not indicate a product deficiency, failure or issue.This is not an event associated with a product failure, malfunction or issue.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Complaint/primary surgery - surgeon went to put in the insert but it wasn't seated completely in the baseplate.Hospital discarded a more detailed description from agent: surgeon was attempting to impact the final poly implant into the tibial baseplate but couldn't get the anterior aspect to fully seat/lock.It was good on the posterior side.Surgeon pulled out another poly which seated/locked fine.

• Brand Name: EMPOWR PARTIAL KNEE
• Common Device Name: EMPOWR PARTIAL KNEETM, TIBIAL INSERT, SIZE 6, 8MM
• 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: kiersten soderman ; 9800 metric blvd.; austin, TX 78758-5445
• MDR Report Key: 11163271
• Report Number: 1644408-2020-01264
• Device Sequence Number: 19654723
• Product Code: HSX
• UDI-Device Identifier: 00190446294917
• UDI-Public: (01)00190446294917
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• 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,Followup
• Report Date (Section B): 11/09/2021

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: 06/22/2025
• Device Model Number: 347-08-706
• Device Catalogue Number: 347-08-706
• Device Lot Number: 168Z1007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 03/02/2021; 04/27/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/30/2021; 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male