MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA FEM CEMENTED SIZ 3,L-MEDIAL; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	IBAL UKA FEM CEMENTED SIZ 3,L-MEDIAL
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/14/2014
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported by a patient¿s legal representative that after an in initial knee surgery on (b)(6) 2014 the patient developed pain in 2018.It was further reported that there was "consecutive wear of the pe inlay" and the implant was removed during a revision surgery.No further information was provided.17-dec-2020 update: further information was provided that the inlay wear was initially diagnosed on the ((b)(6) 2018 and later on the (b)(6) 2018 inlay wear with consecutive wear was diagnosed.Therefore, a revision surgery was performed on (b)(6) 2018 and the following devices were explanted: ibalance uni tibial tray (ar-501-ttlb), ibalance uni tibial bearing (ar-501-tb8) and ibalance uni femoral (ar-501-uflc).The revision was completed using another manufacturer¿s product.
Additional Manufacturer Narrative
The devices were received along with x-rays and evaluated by product management.The evaluation of the x-rays revealed that surgically induced defects/errors are clearly evident in the context of the primary treatment.The femoral component is clearly inserted in varus positioning, resulting in an almost punctual load on the lateral side of the femoral component.Furthermore, there is nearly no slope in the tibial component.As a consequence, a valgus leg axis results in the post op images.In addition, an anterior slip is seen radiologically as a sign of insufficiency of the anterior cruciate ligament.Whether this was damaged during primary implantation/treatment or developed traumatically in the course of treatment cannot be assessed at present.The evaluation of the components showed grinding marks due to implantation of the femoral component in varus along with posterior/ medial wear of the pe and tibial base plate due to acl insufficiency.Nevertheless, the overall course is not due to the implant but to the surgical treatment.

• Brand Name: IBAL UKA FEM CEMENTED SIZ 3,L-MEDIAL
• Common Device Name: 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 Key: 11134823
• Report Number: 1220246-2021-02458
• Device Sequence Number: 19757577
• Product Code: KRR
• UDI-Device Identifier: 00888867034266
• UDI-Public: 00888867034266
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: IBAL UKA FEM CEMENTED SIZ 3,L-MEDIAL
• Device Catalogue Number: AR-501-UFLC
• Device Lot Number: 108761135
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown