MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR PS KNEE; EMPOWR PS KNEETM TIBIAL INSERT, SIZE 6, 12MM

Model Number	343-12-706
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Revision surgery - patient infected, removed poly.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as an infection.The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established.Initial or prolonged hospitalization was required.The healthcare professional indicated there was a serious risk to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were disposed of at hospital and not made available to djo surgical for examination.This investigation is limited in scope as limited information was provided to djo surgical for review.The lot number of the device involved in this event was not provided.To adequately investigate this event, lot number is necessary.In addition to the lot number not being supplied, information regarding cultures identified in the infection and the severity of the infection was not supplied.A review of the device history record (dhr) was not conducted since the lot number was not provided or determined during the complaint evaluation.No additional information was obtained to assist in the event identification.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 a revision surgery due to an infection.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the possible infection or inhibited the patient's immune system.There are multiple factors that may contribute to an event that are outside the control of djo surgical.With the limited information provided about the patient and the devices removed during the revision surgery, it is impossible to determine the source of the infection.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Revision surgery - patient infected, replaced empowr-p.S.Poly.Size 6x12mm.
Additional Manufacturer Narrative
Corrected data: see b.5., d.4., d.10.& h.10.Manufacturer narrative: the reason for this revision surgery was reported as an infection.The previous surgery and the surgery detailed in this event occurred 29 days apart for the left knee and 5.6 months apart for the right knee.The healthcare professional indicated there was a serious risk to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were disposed of at hospital and not made available to djo surgical for examination.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was reported as an infection.There were no findings during this evaluation that indicate the reported devices were the source or had a direct connection with the patient's infection.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the possible infection or inhibited the patient's immune system.Due to the short time between the original surgery and the revision, it is possible that the infection was acquired in the hospital (nosocomial).It is also possible that the patient was not compliant with post surgical instructions.There are multiple factors that may contribute to an infection that are outside the control of djo surgical.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.

• Brand Name: EMPOWR PS KNEE
• Common Device Name: EMPOWR PS KNEETM TIBIAL INSERT, SIZE 6, 12MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 12088878
• Report Number: 1644408-2021-00663
• Device Sequence Number: 14446879
• Product Code: JWH
• UDI-Device Identifier: 00888912172226
• UDI-Public: (01)00888912172226
• 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: 2021
• Device Explanted 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,Followup
• Report Date (Section B): 08/18/2021

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: 01/23/2022
• Device Model Number: 343-12-706
• Device Catalogue Number: 343-12-706
• Device Lot Number: 021U1010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 06/29/2021; 08/09/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/13/2021; 08/18/2021
• 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: 343-12-706 LOT 021U1025
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 63 YR