MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA KNEE - FIXED TIBIAL PLATE CEMENTED #5; TIBIAL PLATE #5

Model Number 6522.15.050

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Implant Pain (4561)

Event Date 09/26/2023

Event Type  Injury  

Event Description

Revision surgery of physica system ps, performed on (b)(6) 2023, due to loosening of physica fixed tibial plate #5 (product code: 6522.15.050, lot.Nr.1908098 - sterilization nr.1900222).Patient is female, 76 years old.Activity level: sedentary.According to the received information the following implants got explanted: physica fixed tibial plate #5 (product code: 6522.15.050, lot.Nr.1908098 - sterilization nr.1900222); physica ps femur comp.Left #5 (product code: 6515.09.550, lot.Nr.19as0cr - sterilization nr.1900360); physica ps tibial liner #5 (product code: 6535.50.510, lot.Nr.19bc017 - sterilization nr.1900278).Event occurred in germany.

Manufacturer Narrative

Checking the manufacturing charts of involved lot number.1908098, no pre-existing anomalies were found on the components manufactured with that lot number.This is the first and only complaint reported on the involved lot number.We will submit a final report after the conclusion of the investigation.

• Brand Name: PHYSICA KNEE - FIXED TIBIAL PLATE CEMENTED #5
• Type of Device: TIBIAL PLATE #5
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18245793
• MDR Text Key: 329477467
• Report Number: 3008021110-2023-00141
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K141934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2023

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 Model Number: 6522.15.050
• Device Lot Number: 1908098
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/01/2023
• 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 Sex: Female
• Patient Weight: 75 KG