MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA TT FIX. TIBIAL TRAY #3

Model Number 6521.14.030

Device Problem Insufficient Information (3190)

Patient Problem Joint Laxity (4526)

Event Date 01/23/2023

Event Type  Injury  

Event Description

Patient had revision surgery on (b)(6) 2023 due to instability, dislocation, and loss of range of motion.According to the complaint source the surgeon during the control visit of (b)(6) 2023 noted that there was a tilting of the tibial implant (commercial code #6521.14.030 - lot# 2123061 - ster.#2200110).The first surgery took place on (b)(6) 2022.Patient is female, date of birth: (b)(6) 1963.This event occurred in france.

Manufacturer Narrative

The check of the device history record of lot #2123061 showed no pre-existing anomalies on the 19 tibial components released with this lot number.Limacorporate has not registered any other complaints related to lot #2123061.We will submit a final report as soon as the investigation will be completed.

• Brand Name: PHYSICA TT FIX. TIBIAL TRAY #3
• Type of Device: PHYSICA TT FIX. TIBIAL TRAY #3
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via naizonale 52; villanova di san daniele, udine 33038
• MDR Report Key: 16350904
• MDR Text Key: 309268878
• Report Number: 3008021110-2023-00011
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): Y
• PMA/PMN Number: K201084
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 6521.14.030
• Device Catalogue Number: 6521.14.030
• Device Lot Number: 2123061
• 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