MAUDE Adverse Event Report: ENCORE MEDICAL L. P. EMPOWR PS KNEE SYSTEM; EMPOWR PS KNEETM TIBIAL INSERT, SIZE 10, 12MM

Model Number 343-12-710

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Scarring (2061)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was due to persistent patellofemoral pain.The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The healthcare professional indicated there was no delay in surgery and another suitable device was available.The revision surgery was completed as intended and without incident.The device was disposed of at the hospital and not made available to djo surgical for examination.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 Description

Revision surgery - due to patient having persistent patellofemoral pain, the patella was previously unresurfaced (native).The insert was explanted in order to gain room for removal of scar tissue.The patella was resurfaced.

• Brand Name: EMPOWR PS KNEE SYSTEM
• Type of Device: EMPOWR PS KNEETM TIBIAL INSERT, SIZE 10, 12MM
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd; austin, tx
• Manufacturer (Section G): ENCORE MEDICAL L. P.; 9800 metric blvd; austin, tx
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, tx
• MDR Report Key: 10289972
• MDR Text Key: 199457064
• Report Number: 1644408-2020-00646
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00888912172264
• UDI-Public: (01)00888912172264
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/16/2020

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
• Device Operator: No Information
• Device Model Number: 343-12-710
• Device Catalogue Number: 343-12-710
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR