MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; TRULIANT TIB IMP PS INSERT SZ 5 10MM

Model Number	02-022-35-5010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); No Information (3190)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation.Concomitant medical products: 200-02-35, 5310441, three peg patella 35mm.
Event or Problem Description
It was reported that the patient had their index surgery on (b)(6) 2018.Patient's knee was revised.He was doing the revision because the patients¿ knee was tight in flexion.The surgeon opened the joint in standard fashion.He decided to lower the poly to a size nine and changed the patella to a 35 mm.The patient had better flexion after this.The surgeon implanted the final implants and closed the knee in standard fashion.The patient left the or in stable condition.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that as reported, the right knee initial implant surgery was on (b)(6) 2018.On (b)(6) 2019, the 79 y/o male patient had a right knee revision due to the patient¿s knee was tight in flexion.The joint was opened in standard fashion.The surgeon decided to lower the poly to a size nine and changed the patella to a 35 mm.The patient had better flexion after this.The final implants were inserted, and the knee was closed in standard fashion.The patient left the operating room in stable condition.The implants will not be returned and were disposed of by the hospital.Patient was last known to be in stable condition following the event.All available information has been received at this time.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the range of motion and subsequent revision cannot be conclusively determined since the devices were not returned; however, it is most likely is related to procedural factors during the index procedure related to the physician¿s choice of implant sizes.(d11) concomitant device(s): concomitant device: truliant ps cem femoral, right sz 5 (cat# 02-020-11-0350, sn: unk).Truliant tibial fit tray cem sz 5f/4t (cat# 02-022-45-5040, sn: unk).Three peg patella 38mm (cn: 200-02-38, sn: unk).
Event or Problem Description
As reported, the initial implant surgery on the right knee was on (b)(6) 2018.On (b)(6) 2019, the 79 y/o male patient had a right knee revision due to the patient¿s knee was tight in flexion.The joint was opened in standard fashion.The surgeon decided to lower the poly to a size nine and changed the patella to a 35 mm.The patient had better flexion after this.The final implants were inserted, and the knee was closed in standard fashion.The patient left the or in stable condition.The implants will not be returned and were disposed of by the hospital.Patient was last known to be in stable condition following the event.All available information has been received at this time.

• Brand Name: TRULIANT
• Common Device Name: TRULIANT TIB IMP PS INSERT SZ 5 10MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9239969
• Report Number: 1038671-2019-00533
• Device Sequence Number: 11235989
• Product Code: JWH
• UDI-Device Identifier: 10885862304629
• UDI-Public: 10885862304629
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 09/14/2025
• Device Model Number: 02-022-35-5010
• Device Catalogue Number: 02-022-35-5010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR