MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB BEARING,SZ 2,10MM; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number IBAL UKA TIB BEARING,SZ 2,10MM

Device Problems Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 11/06/2015

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported by the patient's legal representative that the patient had undergone a left knee menisectomy and "chrondroplasty" on (b)(6) 2015.Thereafter, on (b)(6) 2015 the patient had a hemi-arthroplasty on her left knee.The records provided list that the following arthrex products were implanted during the (b)(6) 2015 procedure: ar-501-ttlb ibalance uni-tibial tray (lot 108761228), ar-501-uflc ibalance uni-femoral implant (lot 1470559) and ar-501-tbb0 ibalance uka tibial bearing (lot 77941142).On (b)(6) 2015 the patient underwent another surgery converting the uni-knee to a total knee replacement.According to the medical records the pre-op diagnosis, and x-ray findings prior to the (b)(6) 2015 procedure note a loose femoral component.However, the operative report notes that the tibial baseplate was loose, not the femoral component.During the procedure the hemi-arthroplasty implants were removed and the following left tka ibalance system components were implanted: ar-503-tttd tibial baseplate (lot 1297044), ar-517-4l femoral implant (lot 1438430), ar-503-a313 tibial bearing implant (13mm) (lot 113601414) and ar-504-psa8 patella implant (lot 113601322).Another manufacturer's bone cement was used with the arthrex implants.The medical records provided note that the patient¿s bmi was 38+ which is a contraindication for both the uni and tka devices.

• Brand Name: IBAL UKA TIB BEARING,SZ 2,10MM
• 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 Key: 8086832
• MDR Text Key: 127860257
• Report Number: 1220246-2018-00763
• Device Sequence Number: 1
• Product Code: KRR
• UDI-Device Identifier: 00888867033825
• UDI-Public: 00888867033825
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/30/2016
• Device Model Number: IBAL UKA TIB BEARING,SZ 2,10MM
• Device Catalogue Number: AR-501-TBB0
• Device Lot Number: 77941142
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/24/2018
• Date Manufacturer Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/28/2011
• 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 Age: 44 YR
• Patient Weight: 93