MAUDE Adverse Event Report: ARTHREX, INC. IBAL PATLOFEM IMPL,SZ 3,RT; KNEE PROSTHESIS PAT/FEM/TIB

Model Number	IBAL PATLOFEM IMPL,SZ 3,RT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patellofemoral implant ar-502-3r was implanted into the patient 5 years ago.The implant now broke off post-op and had to be revised.The revision surgery was performed on friday (b)(6) 2024.No further information was provided.Update avoe 17-oct-2024.It was confirmed that during the revision surgery the broken device was removed with great effort and a new implant was inserted.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.Per dfu-0183-3.E warnings 10.Detailed instructions on the use and limitations of this device, the patient leaflet and the patient implant card should be given to the patient.Patient conditions can affect results and outcomes.Performing activities that increase stresses on implants such as running, lifting, skiing, etc.Can result in early failure of these implants.Postoperatively and until healing is complete, the fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.This product¿s useful life will vary between patients and is dependent upon accumulated weight-bearing activities and lifestyle.16.Physicians should carefully assess the activity level of the patient prior to performing arthroplasty of the knee.Increased activity as well as increased weight can lead to accelerated wear of uhmwpe components.According to the x-rays sent by the customer, it can be seen that one of the ends of the ibalance¿ pfj, patellofemoral implant, cemented size 3, right was broken.The most likely cause for the reported failure can be attributed to a patient-specific event.
Event or Problem Description
Update avoe on 05-nov-2024: it was further reported that in addition to the reported device also a patella implant was used, which did not need to be replaced, as it wasn`t damaged beside slight signs of use.According to the surgeon, there was no trauma that caused the device breakage.However, the tuberosity was osteotomized.The osteotomy is a possible cause for the device breakage.

• Brand Name: IBAL PATLOFEM IMPL,SZ 3,RT
• Common Device Name: KNEE PROSTHESIS PAT/FEM/TIB
• 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: jared engle ; 8009337001
• MDR Report Key: 20556665
• Report Number: 1220246-2024-08293
• Device Sequence Number: 3250460
• Product Code: KRR
• UDI-Device Identifier: 00888867034587
• UDI-Public: 00888867034587
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K171365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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 Model Number: IBAL PATLOFEM IMPL,SZ 3,RT
• Device Catalogue Number: AR-502-3R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown