MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number TRULIANT TIB IMP PS INSERT SZ 2.5 11MM

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Joint Laxity (4526)

Event Date 07/18/2022

Event Type  Injury  

Event Description

It was reported that a 69 yo female patient, who was initially implanted on the right knee on (b)(6) 2021, underwent a poly swap revision surgery approximately 1 year 1 month post the initial implant procedure due to instability.They increased poly thickness from a 11mm ps insert to a 15mm psc insert and were revised to exactech devices.Patient was last known to be in stable condition following the event.Due to hospital policies, no products are available for return.No additional information is available.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

Manufacturer Narrative

Concomitant medical products: 02-020-11-0325 - truliant ps cem fem ps cem right sz 2.5, 6792590; 02-022-45-2525 - truliant tib fit tray cem sz 2.5f / 2.5t, 6531018; 200-02-35 - three peg patella 35mm, 6470897; 201-78-15 - holding pin mini sharp point 4 pk, 6790703; 521-78-23 - threaded pin size 2.3 collared 2pk, s265617; 521-78-31 - threaded pin size 2.6 collarless 2pk, s110679.No device returning due to hospital policies.Recall: z-2112 thru 2133-2021.

Manufacturer Narrative

H7: z-0023-2022.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 2.5 11MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15257980
• MDR Text Key: 298207799
• Report Number: 1038671-2022-00945
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862304186
• UDI-Public: 10885862304186
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 2.5 11MM
• Device Catalogue Number: 02-022-35-2511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female