MAUDE Adverse Event Report: LIMACORPORATE SPA PHYSICA FIXED TIBIAL PLATE #6 (HRY JWH)

Model Number 6522.15.060

Device Problems Loose or Intermittent Connection (1371); Failure to Osseointegrate (1863)

Patient Problem Failure of Implant (1924)

Event Date 05/18/2020

Event Type  Injury  

Manufacturer Narrative

By the check of the dhrs, no pre-existing anomaly was found on the 35 physica fixed tibial plates #6 (code 6522.15.060) placed on the market with lot# 1803405.First and only complaint received on the same lot#.We will submit a final mdr once the investigation will be completed.

Event Description

Knee revision surgery due to loosening of the cemented tibial plate (code 6522.15.060, lot 1803405).Surgeon commented that bone did not adhere to cement.Previous surgery took place on (b)(6) 2018, revision surgery on (b)(6) 2020.According to information received, the patient had a car incident (date unknown).Event happened in the usa.

• Brand Name: PHYSICA FIXED TIBIAL PLATE #6 (HRY JWH)
• Type of Device: TIBIAL PLATE #6
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10166941
• MDR Text Key: 199846318
• Report Number: 3008021110-2020-00039
• Device Sequence Number: 1
• Product Code: HRY
• 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
• Type of Report: Initial

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: No Information
• Device Model Number: 6522.15.060
• Device Lot Number: 1803405
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2020
• 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