MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR 3D KNEETM, PRESS FIT FEMUR, 9R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS

Catalog Number 243-02-109

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Laxity (4526); Muscle/Tendon Damage (4532)

Event Date 03/06/2024

Event Type  Injury  

Event Description

Revision surgery - due to patient fell.Femoral components clasped into valgus post op.Femur failed after patient fell post op.

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2024-00447; 243-02-110, s809 - trauma, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: EMPOWR 3D KNEETM, PRESS FIT FEMUR, 9R
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 19056501
• MDR Text Key: 339548596
• Report Number: 1644408-2024-00408
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00190446231400
• UDI-Public: 00190446231400
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171991
• 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,Followup
• Report Date: 05/11/2024

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: Health Professional
• Device Catalogue Number: 243-02-109
• Device Lot Number: 288W1092
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 04/06/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 05/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/27/2022
• 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
• Treatment: 342-12-710 LOT: 124T1083
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male