MAUDE Adverse Event Report: LIMACORPORATE S.P.A PHYSICA TT FIX. TIBIAL TRAY #5

Model Number 6521.14.050

Device Problem Insufficient Information (3190)

Patient Problem Joint Laxity (4526)

Event Date 04/19/2023

Event Type  Injury  

Manufacturer Narrative

By the check of the device history records of the lot number involved (2202412), no pre-existing anomaly that could have contributed to the reported issue was detected on the tibial plates released with the same lot number.This is the first and only complaint received on this lot number.We will submit a final report as soon as the investigation will be completed.

Event Description

Knee revision surgery due to loosening of the physica tt fix.Tibial tray #5, commercial code 652114050 - lot #2202412 - ster.#2200182 the complaint source reported that the implant had tilted.The revision surgery date was (b)(6) 2023, the date of the previous surgery is (b)(6) 2023.Patient is female date of birth - (b)(6)1951.Approx.Height = 165.00cm.Approx weight =69kg.Occupation - retired.Activity level = strongly reduced.Bmi =25.34.

• Brand Name: PHYSICA TT FIX. TIBIAL TRAY #5
• Type of Device: PHYSICA TT FIX. TIBIAL TRAY #5
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale, 52; villanova di san daniele, udine 33038
• MDR Report Key: 16900702
• MDR Text Key: 314887957
• Report Number: 3008021110-2023-00047
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• 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: 05/05/2023

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: 6521.14.050
• Device Catalogue Number: 6521.14.050
• Device Lot Number: 2202412
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2023
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 69 KG