MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 1.5, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP PSC INSERT SZ 1.5, 15MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products.Truliant ps cem fem ps cem right sz 1.5 (cat# 02-020-11-0315 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately two years post initial right side tka, this female patient was having right knee patella dislocations.The poly insert was removed and the femoral prosthesis was removed.The patient received a size 1 right logic cc femur,12x80 cemented stem, and a 13mm poly insert.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays received.The devices are not available for evaluation due to the hospital sent off implants with tissue.
Additional Manufacturer Narrative
As reported, approximately two years post initial right side tka, this female patient was having right knee patella dislocations.The poly insert was removed and the femoral prosthesis was removed.The patient received a size 1 right logic cc femur,12x80 cemented stem, and a 13mm poly insert.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays attached.The devices are not available for evaluation due to the hospital sent off implants with tissue.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 dislocation and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and the result of loosened supporting ligaments and muscles, which allowed for dislocation occurring due to the significant ligament re-construction.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 1.5, 15MM
• Common Device Name: 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: 13709303
• Report Number: 1038671-2022-00243
• Device Sequence Number: 20452220
• Product Code: JWH
• UDI-Device Identifier: 10885862304865
• UDI-Public: 10885862304865
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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 Model Number: TRULIANT TIB IMP PSC INSERT SZ 1.5, 15MM
• Device Catalogue Number: 02-022-44-1515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Female