MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR PS KNEE; EMPOWR PS KNEETM FEMUR, NONPOROUS, 8R

Model Number	242-02-108
Health Effect - Clinical Codes	Fall (1848); Tissue Damage (2104)
Date of Event	10/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as damage of soft tissue from a fall.The previous surgery and the surgery detailed in this event occurred 1 year and 1 month apart.The healthcare professional indicated 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 was a nonconformance associated with the main part #242-02-108, empowr ps kneetm femur, nonporous, 8r which documents that out of 9 parts lot, 3 parts were rejected and scrapped due to dimension out of tolerance.All other item in the lot were met with the design, fit and function requirements.The devices were verified to have gone through an acceptable sterilization process and were within its expiration dates 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 a revision surgery due to damage of soft tissue from a fall.There were no findings during this evaluation that indicate the reported devices were defective.No other 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 event.Agent has clearly mentioned that the soft tissue was damaged due to initial fall it seems that the event may occurred due to, patient noncompliance with medical instructions, lack of care, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Second revision surgery - after suffering a fall post operative of the primary knee surgery, the surgeon converted the femur component to a ps femur component.Due to soft tissue damage from the initial fall issues with the patient persisted and he decided the best outcome was to remove all implants and implant a hinge style prosthesis.

• Brand Name: EMPOWR PS KNEE
• Common Device Name: EMPOWR PS KNEETM FEMUR, NONPOROUS, 8R
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9343005
• Report Number: 1644408-2019-01097
• Device Sequence Number: 19385180
• Product Code: JWH
• UDI-Device Identifier: 00888912171885
• UDI-Public: (01)00888912171885
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2019

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: 05/30/2024
• Device Model Number: 242-02-108
• Device Catalogue Number: 242-02-108
• Device Lot Number: 871T1093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/19/2019
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 76