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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC.; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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ARTHREX, INC.; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Lot Number 5791631
Device Problems Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Muscle Weakness (1967); Pain (1994)
Event Date 10/22/2020
Event Type  Injury  
Event Description
On 7/25/2022, it was reported through a patient¿s legal filing that on (b)(6) 2017 the patient underwent a left knee uni-compartmental knee arthroplasty.During the procedure the surgeon implanted an arthrex ibalance uni-compartmental knee system with a size 3 femoral component, size 4 tibial tray, and an 8 mm tibial bearing insert into the left knee medial parapatellar facetectomy.Thereafter the patient was having pain in the left knee and on (b)(6) 2019 and mri of the knee was taken which revealed ¿metallic artifact is present involving the medial compartment obscuring and distorting the underlying and adjacent structures.¿ on (b)(6) 2019 the patient reported a crunching sensation on the medial aspect of the knee.On (b)(6) 2019 and again on (b)(6) 2020 the patient complained of aches, pains and weakness in the knee.On (b)(6) 2020 the patient presented to another surgeon and a bone scan was ordered which revealed a loose implant.The patient was referred to another surgeon to discuss revision options due to loosening of the implant and on (b)(6) 2020 that surgeon performed an ex-plantation and antibiotic spacer placement, left total knee arthroplasty and saucerization of femoral tibial bone for infection.It is unknown what manufacturers devices were used for the revision total knee arthroplasty.The patient continued to report issues and a second total knee revision arthroplasty was performed on (b)(6) 2020.It is unknown what devices were explanted and what manufacturers devices were used in the second revision surgery.No further information has been provided to date.
 
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Manufacturer Narrative
The complaint cannot be confirmed based on the customer provided photo, which does not display the failed implant.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.
 
Manufacturer Narrative
The complaint cannot be confirmed based on the customer provided photo, which does not display the failed implant.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.
 
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Brand Name
UNK
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key15226295
MDR Text Key297903785
Report Number1220246-2022-05379
Device Sequence Number1
Product Code KRR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152252
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup,Followup
Report Date 10/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot Number5791631
Was Device Available for Evaluation? No
Date Manufacturer Received07/25/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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