MAUDE Adverse Event Report: LIMACORPORATE SPA PHYSICA TT FIX. TIBIAL TRAY #5; PHYSICA TT TIBIAL PLATE #5

Model Number 6521.14.050

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Joint Laxity (4526)

Event Date 12/06/2021

Event Type  Injury  

Manufacturer Narrative

The device history records of the device involved were check and no pre-existing anomaly was detected on the 14 tibial plates released with lot number 2100066 ster.2100051.This is the first and only complaint registered on this lot number.A final report will be submitted after the conclusion of the investigations.

Event Description

Knee revision surgery due to loosening of the of physica tt tibial plate (product code 6521.14.050, lot 2100066), after 45 days from the original surgery.Revision surgery date is (b)(6), 2021, previous surgery date is (b)(6), 2021.This incident occurred in (b)(6).

Event Description

Knee revision surgery due to loosening of the of physica tt tibial plate (product code 6521.14.050, lot n.2100066), after 45 days from the original surgery.Revision surgery date is (b)(6) 2021, previous surgery date is (b)(6) 2021.During the revision surgery, only the tibial plate was removed and replaced with a physica tibial component (code and lot are not known).Patient was born in (b)(6), male, 1.72 m, 80kg, active smoker.Complaint source reported that the patient is affected by renal failure and has a pacemaker.This event occurred in (b)(6).

Manufacturer Narrative

The device history records of the device involved were check and no pre-existing anomaly was detected on the 14 tibial plates released with lot number 2100066 ster.(b)(4).Therefore, we can state that they were manufactured up to drawing specifications and in line with the relevant checks and tests.According to our records, 11 tibial plates with code 6521.14.050, lot n.2100066 have already been implanted and this is the first and only complaint registered on this lot number.The explanted component was not available to be returned to limacorporate, therefore no specific analysis was performed on it.X-rays images dated (b)(6) 2021, and (b)(6) 2022, were provided to limacorporate by the complaint source.Note: the x-rays dated (b)(6) 2021 appears to be post-operative of the original surgery, complaint source could not confirm which is the correct surgery date (according to complaint source's records, it was (b)(6)).The available information and x-rays were shared with a medical consultant for a clinical evaluation.His comments are reported hereafter: - with reference to x-rays dated (b)(6) 2021, he concluded: "tibial component is correctly placed within the deviation tolerance, tibial component has a dorsal slope of 4,9° and lateral inclination of 1,9°.The tibial component is not in full contact with the resected surface.The femoral component is in flexion of 7,1°" - with reference to x-rays dated (b)(6) 2021, he concluded: "tibial component is subsided and migrated.According to the time interval prom the primary surgery- less than six weeks, such a rapid movement could be caused only due to the very poor primary fixation or the septic loosening." he also stated that patient's age combined with the reported renal failure and active smoking, could have contributed to the poor primary fixation of the cementless device.- with reference to x-rays dated (b)(6) 2021, he concluded: "revision cemented tibial component is placed of the same level-no change of the joint line.Bone cement is penetrated through the peg holes in the metaphysis in the surrounded tissues.On the lateral view there in anterior slope- 6,2° which is compensating the flexion of the 7,1° of the femoral component.This could improve the kinematic of the revision tka." in conclusion, the cause of the reported loosening cannot be determined with certainty, but according to our medical expert such a rapid subsidence and migration of the implant could be related to very poor primary fixation or to septic loosening.This event is classified as not product related.Pms data: limacorporate is not aware of any other case of knee revision surgery due to loosening of physica tt tibial plates (codes 6521.14.Xxx).No corrective action needed following this complaint, limacorporate will continue monitoring the market to promptly detect any further similar event.

• Brand Name: PHYSICA TT FIX. TIBIAL TRAY #5
• Type of Device: PHYSICA TT TIBIAL PLATE #5
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via naizonale 52; villanova di san daniele, udine 33038
• MDR Report Key: 13891913
• MDR Text Key: 289738174
• Report Number: 3008021110-2022-00017
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• 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: 2100066
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2022
• 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
• Patient Outcome(s): Required Intervention