MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA KR FEMUR COMP.RIGHT #8; KR FEMORAL COMPONENT RIGHT #8

Model Number 6511.09.180

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Discomfort (2330); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 11/11/2020

Event Type  Injury  

Manufacturer Narrative

By checking the dhr of the lot #14sa591, no pre-existing anomalies were detected on the pieces manufactured with this lot #.This is the first and only complaint received on this lot #.We will submit a final mdr once the investigation will be completed.

Event Description

Right knee revision surgery performed on (b)(6) 2020 due to loosening of the physica kr femoral right #8 (product code 6511.09.180 lot# 14sa591).Previous surgery was performed on (b)(6) 2015.At the follow up visit for the left knee on (b)(6) 2019, the patient reported pain and discomfort on the right knee.It was reported that on (b)(6) 2019 the x-rays showed signs of loosening of the femoral component of the right knee.According to the reported information, on (b)(6) 2020 the patient was reviewed and had a large effusion in the right knee, which was aspirated.According to the complaint source, the fluid showed no growth in the lab.It was reported that on review of bone scan, it was shown infection was unlikely and the patient was advised to have single stage revision of the right knee replacement.Patient is a male, born on 1942.Bilateral oa knees.It was reported that patient has polymyalgia 2 years.Event happened in (b)(6).

Manufacturer Narrative

By checking the dhr of the lot n.14sa591, no pre-existing anomalies were detected on the femoral components manufactured with this lot number.According to our records, out of 15 femoral components manufactured with lot number 14sa591, at least 14 have already been implanted and this is the first and only complaint received on this lot number.The following x-rays were received by limacorporate and shared with a medical consultant for analysis: x-rays taken before the primary knee replacement surgery, dated (b)(6) 2015; x-rays taken after the primary knee replacement surgery, dated (b)(6) 2015; (b)(6) 2015; (b)(6) 2015; x-rays taken at three years follow up visit, dated (b)(6) 2018; x-rays taken before the knee revision surgery, dated (b)(6) 2020; x-rays taken after the knee revision surgery, dated (b)(6) 2020.Based on the available x-rays analysis, the medical consultant concluded: "femoral component is correctly placed within the deviation tolerance, tibial component has a correct dorsal slope 0° and valgus position of 94,5°.The position of tibial component is optimal and the mild valgus alignment of the leg was preserved.There is 1,9° angle between the components on the x-ray no.3 (dated (b)(6) 2018), which is not seen on the standing x-ray.This could indicate very mild soft-tissue tension discrepancy.There are no signs of any radiolucency lines." "there are no radiological sings of the loosening of the tibial component.The bone cement was penetrating into the cancellous bone in 4,5 and 6 zones.Femoral component debonding from bone-cement in the zone 1 and 2.The reason could be incorrect cementing technique-but in this case the onset is sooner.Debonding of the cement implant interface is relatively uncommon.It is very difficult to identify the exact causes for this type of aseptic loosening.In the literature the debonding is described more often in the modern implants recently introduced to the market without clear identification of this failure." "the primary tka preserved valgus alignment- first signs of femoral component flexion and migration are seen 36 months after primary surgery.There are no radiological sings of the loosening of the tibial component.The position of the revision tibial component is neutral and the alignment of the leg was changed from mild valgus probably to neutral (long-leg x-ray is missing)." the explanted devices were received for analysis.By the visual inspection, cement residues seem visible on the tibial component, while no residue is visible on the femoral component (maybe removed during the decontamination).Following the visual inspection of the devices and considering the type of incident under assessment, no further investigation is considered necessary other than the available x-rays evaluation.In conclusion, a definitive cause of the loosening reported cannot be identified.Considering that the check of the device history records of the lot number involved, confirmed the absence of pre-existing anomalies, we can state that the device was manufactured up to drawing specifications and in line with relevant tests and checks.Based upon the analyses performed, this event is classified as not product-related.Pms data: based on limacorporate pms data, we estimate a revision rate due to loosening of the kr femoral component (family codes 6511.09.Xxx) of about (b)(4).No corrective action needed following this complaint.Limacorporate will continue monitoring the market to promptly detect any further similar event.

Event Description

Right knee revision surgery performed on (b)(6) 2020, due to loosening of the physcia kr femoral component - right #8 (product code 6511.09.180 lot# 14sa591).In addition to the femoral component, the following devices were explanted: kr tibial liner h.10 #7, product code 6531.50.710 lot 1300695; tibial plate #7, product code 6522.15.070 lot 1413038.The previous surgery was performed on (b)(6) 2015.Based on the available information, on (b)(6) 2019, the patient reported pain and discomfort on the right knee.It was reported that on (b)(6) 2019 the x-rays showed signs of loosening of the femoral component of the right knee.Bloods were taken at this appointment, where it was shown they had normal inflammatory markers with a crp of 6.9 and esr 3.According to the reported information, on (b)(6) 2020, the patient was reviewed and had a large effusion in the right knee, which was aspirated.According to the complaint source, the fluid showed no growth in the lab.It was reported that on review of bone scan (taken on (b)(6) 2023), it was shown infection was unlikely and the patient was advised to have single stage revision of the right knee replacement.The revision surgery took place on (b)(6) 2020.Patient data: patient is male, born on 1942.Hight: 171 cm, weight: 71 kg, bmi: 24,28 kg/m2.Normal activity level, job: farmer.The complaint source reported that "patient feels heavy work on farm may have contributed." the following medical history was reported by the complaint source: bilateral oa knees, right calf discolouration post left knee arthroscopy.Right total hip replacement on (b)(6) 2013, polymyalgia 2 years, no steroids.No previous homolateral surgeries, previous heterolateral surgeries: left knee arthroscopy 2012.Diagnosis - 1 degree oa knee.Event happened in great britain.

• Brand Name: PHYSICA KR FEMUR COMP.RIGHT #8
• Type of Device: KR FEMORAL COMPONENT RIGHT #8
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 11627053
• MDR Text Key: 260973891
• Report Number: 3008021110-2021-00025
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 6511.09.180
• Device Lot Number: 14SA591
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2023
• 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