MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA FIXED TIBIAL PLATE #8

Model Number 6522.15.080

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 05/11/2022

Event Type  Injury  

Event Description

Right knee revision surgery due to infection performed on (b)(6) 2022.The previous surgery took place on (b)(6) 2022.The involved components are listed below: physica fixed tibial plate #8 product code 6522.15.080, lot n.2105609, ster.2100165.Physica ps tibial liner #8 product code 6535.50.811, lot n.19bc023, ster.2000265.Physica tibial stem (product information to be confirmed after double check with the hospital).Femoral component (product information unknown).Patella (product information unknown).The patient is (b)(6) years old.This event occurred in (b)(6).

Manufacturer Narrative

The sterilization charts of the involved devices were checked with the following results: no pre-existing anomaly found on the 36 physica fixed tibial plate #8 that belong to product code 6522.15.080, lot n.2105609, ster.2100165.No pre-existing anomaly found on the 53 physica ps tibial liner #8 that belong to product code 6535.50.811, lot n.19bc023, ster.2000265.Therefore we can state that the involved components were regularly sterilized before being placed on the market.We will submit a final mdr after the conclusion of the investigation.

Manufacturer Narrative

The sterilization charts of the involved devices were checked with the following results: no pre-existing anomaly on the 36 physica fixed tibial plate #8 that belong to product code 6522.15.080, lot n.2105609, ster.2100165.No pre-existing anomaly on the 53 physica ps tibial liner #8 that belong to product code 6535.50.811, lot n.19bc023, ster.2000265.No pre-existing anomaly on the 56 physica tibial stem l.20 mm product code 6590.15.020, lot n.2105598, ster.2100174.Therefore, we can state that the involved components were regularly sterilized before being placed on the market.Further information was requested to the complaint source, specifically: cultivation results; pre- operative x-rays and post-operative x-rays of the previous surgery; pre- operative x-rays and post-operative x-rays of the revision surgery; clinical data of the patient.The complaint source shared only one x-ray image taken before the revision surgery, which was sent to our medical consultant.Unfortunately, it was impossible to retrieve further information, so our medical expert could not perform any further clinical evaluation.In conclusion, based on the very few information received, we are not able to further investigate the root cause of the event.We could only check the sterilization charts of the involved devices, which confirm the absence of any pre-existing anomalies.Pms data according to limacorporate pms data, we estimate a revision rate of physica system due to infection of about 0,01%.No specific corrective action is needed for this case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.

Event Description

Right knee revision surgery due to infection performed on (b)(6) 2022.The previous surgery took place on (b)(6) 2021, due to degenerative arthrosis on the right knee.The involved components are listed below: physica fixed tibial plate #8 product code 6522.15.080, lot n.2105609, ster.2100165 physica ps tibial liner #8 product code 6535.50.811, lot n.19bc023, ster.2000265 physica tibial stem l.20 mm product code 6590.15.020, lot n.2105598, ster.2100174 femoral component (product information unknown) patella (product information unknown) the patient is (b)(6).This event occurred in italy.

• Brand Name: PHYSICA FIXED TIBIAL PLATE #8
• Type of Device: TIBIAL PLATE #8
• 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: 14621345
• MDR Text Key: 293647224
• Report Number: 3008021110-2022-00045
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): Y
• PMA/PMN Number: K141934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 6522.15.080
• Device Lot Number: 2105609
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2022
• 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