MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT CR CEM FEM CR CEM RIGHT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT CR CEM FEM CR CEM RIGHT SZ 3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: truliant tib fit tray cem sz 3f / 2t (cat# 02-022-45-3020 / serial# (b)(4)).Truliant tib imp crc insert sz 3, 11mm (cat# 02-022-51-3011 / serial# (b)(4)).Three peg patella 32mm (cat# 200-02-32 / serial# (b)(4)).Holding pin mini sharp point 4 pk (cat# 201-78-15 / serial# (b)(4)).Threaded pin size 2.3 collared 2pk (cat# 521-78-23 / serial# (b)(4)).Threaded pin size 3.0 collarless 2pk (cat# 521-78-32 / serial# (b)(4)).Threaded pin size 3.0 collarless 2pk (cat# 521-78-32 / serial# (b)(4)).Threaded pin size 5.1 collarless 2pk (cat# 521-78-36 / serial# (b)(4)).Gps implant kit v2 (cat# a10012 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 2.5 years post initial tka, this female patient was revised due to pain.A mri and ct scan did not show anything significant per surgeon but suspected poly wear and potentially an issue with the tibia.However during surgery no significant poly wear was noted and the tibia was not loose.The femur however was found to be de-bonded from cement mantle.It was still in original position but was easily worked loose with minimal strikes with a flexible osteotome.The surgeon felt the need to switch to competitor's device for the revision implants.Patient last known to be in stable condition.No further information available.Images and photos received.Explants not available to the rep.
Additional Manufacturer Narrative
(h3) as reported, approximately 2.5 years post initial tka, this female patient was revised due to pain.An mri and ct scan did not show anything significant per surgeon but suspected poly wear and potentially an issue with the tibia.However, during surgery no significant poly wear was noted and the tibia was not loose.The femur however was found to be de-bonded from cement mantle.It was still in original position but was easily worked loose with minimal strikes with a flexible osteotome.The surgeon felt the need to switch to competitor's device for the revision implants.Patient last known to be in stable condition.Images and photos received.Explants not available to the rep.No further information 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.These devices are used for treatment not diagnosis.

• Brand Name: TRULIANT CR CEM FEM CR CEM RIGHT SZ 3
• 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: 14307913
• Report Number: 1038671-2022-00508
• Device Sequence Number: 12011917
• Product Code: JWH
• UDI-Device Identifier: 10885862314673
• UDI-Public: 10885862314673
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 09/14/2022

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 CR CEM FEM CR CEM RIGHT SZ 3
• Device Catalogue Number: 02-020-13-0330
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2018
• 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