MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA FEM CEMENTED SIZ 4,L-MEDIAL; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	IBAL UKA FEM CEMENTED SIZ 4,L-MEDIAL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 08/08/2022, it was reported by a sales representative via email that during a medial uni-compartmental knee replacement a ar-501-ufld ibalance¿ uka femoral,cemented size 4s the cement became to firm when trying to implant the femoral component.Not being able to fully seat the femoral component, the component was then removed as well as the cement removed and a new batch of cement mixed.A 2nd component was opened, as all the prior cement could not be removed from the original implant.It was also found that the tibial acl insertion had avulsed, that was repaired back down to the tibia with a 4.5 cannulated screw and washer, as well as a fibertape fixated with a swivelock into the proximal tibia.The case was completed, with no patient effect reported.
Additional Manufacturer Narrative
Visual inspection found on the proximal side of the device a significant amount of cement on the device.The hardening of the cement is an expected process.Possible causes of the cement hardening include misuse of the device leaving significant time for the cement to cure before seating of the device was attempted or the cement possibly cured faster than expected.However, no issues were noted with ar-501-ufld.Complaint was not confirmed.

• Brand Name: IBAL UKA FEM CEMENTED SIZ 4,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: 15310539
• Report Number: 1220246-2022-05414
• Device Sequence Number: 16843580
• Product Code: KRR
• UDI-Device Identifier: 00888867034273
• UDI-Public: 00888867034273
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K160461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2022

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: 06/30/2026
• Device Model Number: IBAL UKA FEM CEMENTED SIZ 4,L-MEDIAL
• Device Catalogue Number: AR-501-UFLD
• Device Lot Number: 13776076
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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