MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA FIXED TIBIAL PLATE #3; PHYSICA FIXED TIBIAL PLATE #3,

Model Number 6522.15.030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 01/25/2023

Event Type  Injury  

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the lot numbers involved (2201407, 1923273, 2125754).This is the first and only complaint registered on these lot numbers.We will submit a final report as soon as the investigation will be completed.

Event Description

Knee revision surgery due to pain performed on (b)(6) 2023.The following components were explanted: physica ps - femoral peg, code 651509900, lot 2201407.Physica fixed tibial plate #3, code 652215030 lot 1923273.Physica tibial stem l.20mm, code 659015020 , lot 2125754.According to the information received, the femoral component and a screw were also explanted, but their product details are not known.The previous surgery took place on (b)(6) 2022.Patient is 72 years old.This event occurred in italy.

Event Description

Knee revision surgery due to pain performed on (b)(6) 2023.The following components were explanted: physica ps - femoral peg (product code: 6515.09.900, lot 2201407).Physica fixed tibial plate #3 (product code: 6522.15.030, lot 1923273 - ster.2000020).Physica tibial stem l.20mm (product code: 6590.15.020, lot 2125754 - ster.2200057).According to the information received, the femoral component and a screw were also explanted, but their product details are not known.The previous surgery took place on (b)(6) 2022.Patient is 72 years old.Event occurred in italy.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot nr.2201407, no pre-existing anomaly was found on a total of (b)(4) items manufactured with the same lot number.According to our records, at least 49 out of 50 with lot nr.2201407 have been implanted and this is the only complaint received on this lot nr.Checking the manufacturing charts of the involved lot nr.1923273, no pre-existing anomaly was found on a total of (b)(4) items manufactured with the same lot number.According to our records, at least 18 out of 18 with lot nr.1923273 - ster 2000020 have been implanted and this is the only complaint received on this lot nr.Checking the manufacturing charts of the involved lot nr.2125754, no pre-existing anomaly was found on a total of (b)(4) items manufactured with the same lot nr.According to our records, at least 55 out of 56 with lot nr.2126300 - ster.2200057 have been implanted and this is the only complaint received on this lot nr.Even though requested the following details were not provided to limacorporate: patient clinical data.Specific lot of femoral components and a screw explanted.Additional x-rays.Limacorporate received from complaint source only two x-rays referring to pre-operative revision surgery, without a precise date.The information available and x-rays received were sent for evaluation to our medical consultant.Unfortunately, the available information was insufficient so our medical expert stated he could not perform any further clinical evaluation.Therefore, considering that: check of the manufacturing charts highlighted no pre-existing anomalies on the total number of components manufactured with the involved lot numbers: 2201407, 1923273 and 2125754.X-rays and information provided were not sufficient to perform a clinical analysis by our medical expert.We are not able to perform further investigation, other than the check of manufacturing charts.We classify the event as not product related.Pms data: according to limacorporate pms data, we estimate a revision rate of physica tibial plate (family code: 6522.15.Xxx) due to pain of about (b)(4).No specific corrective action is needed for this case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.This is a final mdr report.

• Brand Name: PHYSICA FIXED TIBIAL PLATE #3
• Type of Device: PHYSICA FIXED TIBIAL PLATE #3,
• 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 33038
• MDR Report Key: 16361358
• MDR Text Key: 309369152
• Report Number: 3008021110-2023-00013
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 6522.15.030
• Device Lot Number: 1923273
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2023
• 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