MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA TT; PHYSICA TT - TI6AL4V EBM - FIXED TIBIAL PLATE #7 UNCEMENTED

Model Number	6521.14.070
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of involved lot numbers, 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 numbers.A final report will be sent after the investigation is completed.
Event or Problem Description
Knee revision surgery performed on (b)(6) 2023, due to early mobilization of physica tt fix.Tibial tray #7 (product code: 6521.14.070, lot nr.2218966, ster.Nr.2200275).During the procedure physica cemented tibial plated size 7 was implanted.The following devices were explanted during revision: physica tt fix.Tibial tray #7 (product code: 6521.14.070, lot nr.2218966, ster.Nr.2200275).Physica ps tibial liner #7 (product code: 6535.50.710, lot.Nr.22bc06g, ster.Nr.2200141).The following devices remained implanted: physica ps - femoral peg (product code: 6515.09.900, lot.Nr.1811518, ster.Nr.1800255).Femoral component #7 left (product code: 6515.10.570, lot nr.2109698, ster.Nr.2100357) event occurred in italy.
Event or Problem Description
Knee revision surgery performed on (b)(6) 2023, due to early mobilization of physica tt fix.Tibial tray #7 (product code: 6521.14.070, lot nr.2218966, ster.Nr.(b)(4)).The following devices were explanted during revision: physica tt fix.Tibial tray #7 (product code: 6521.14.070, lot nr.2218966, ster.Nr.(b)(4)) - sold in us.Physica ps tibial liner #7 (product code: 6535.50.710, lot.Nr.22bc06g, ster.Nr.(b)(4)) - sold in us.The following devices remained implanted: physica ps - femoral peg (product code: 6515.09.900, lot.Nr.1811518, ster.Nr.(b)(4)).Femoral component #7 left (product code: 6515.10.570, lot nr.2109698, ster.Nr.(b)(4)).Event occurred in italy.
Additional Manufacturer Narrative
Investigation: by the check of the device history records of the lot number involved (lot.Nr.2218966), no pre-existing anomaly that could have contributed to the reported issue was detected on the 15 tibial plates released with lot nr.2218966, ster.Nr.(b)(4).Therefore, we can state that they were manufactured up to drawing specifications and in line with the relevant checks and tests.This is the first and only complaint received on lot number: 2218966.The explanted component was returned to limacorporate and from a visual inspection it seems that there is no bone growth.The available information and a pre-revision x-ray (exact date unknown) were shared with a medical consultant for a clinical evaluation.His comments are reported hereafter: "looking at the x-rays, i would say one size bigger tt tibial plate should be used for the primary implantation.The tibial slope is also too big on the lateral x-ray, but this is already after the tibial loosening occurred.So, i cannot comment if excessive slope was already done at primary operation.If the patient is young and active, an undersized tt tibial plate with too early and too active patients can lead to the early failure of the tt tibia.In this case i would say the patient was too much active in the early phase of post-operative rehabilitation after primary tka and therefore early tibial loosening occurred " in conclusion, the cause of the reported loosening cannot be determined with certainty, but according to our medical expert opinion, one size bigger tt tibial plate should be used for the primary implantation and in addition maybe the patient was too much active in the early phase of post-operative rehabilitation after primary tka and therefore early tibial loosening occurred.This event is classified as not product related.Pms data according to pms data the revision rate due to physica tt tibial plates (code (b)(4)) loosening is about (b)(4).Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.This is a final mdr report.

• Brand Name: PHYSICA TT
• Common Device Name: PHYSICA TT - TI6AL4V EBM - FIXED TIBIAL PLATE #7 UNCEMENTED
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18377652
• Report Number: 3008021110-2023-00148
• Device Sequence Number: 18070207
• Product Code: MBH
• UDI-Device Identifier: 08033390174305
• UDI-Public: 08033390174305
• Combination Product (Y/N): N
• PMA/510(K) Number: K201084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: 6521.14.070
• Device Lot Number: 2218966
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 06/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown