MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS SLOPE++ SZ 2 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-49-2011
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Scar Tissue (2060); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-022-47-2013 - truliant tib imp cr ins std sz 2, 13mm; (b)(6), 203-96-64 - sawblades ez1913.M62 90x19, 1.27mm strkr5/6/7; (b)(6), 02-020-13-0220 - truliant cr cem fem cr cem left sz 2; (b)(6), 02-022-45-2020 - truliant tib fit tray cem sz 2f / 2t; (b)(6), 200-07-32 - advanced patella 32mm 3 peg implant; (b)(6), 201-78-15 - holding pin mini sharp point 4 pk; (b)(6), 521-78-31 - threaded pin size 2.6 collarless 2pk; (b)(6), 521-78-32 - threaded pin size 3.0 collarless 2pk.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that approximately 33 months after a left knee replacement procedure, the patient underwent a revision procedure to address polyethylene wear, mild synovium, instability and swelling.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
H6: corrected health effect clinical code, medical device problem code, type of investigation.The reason for the revision reported cannot be confirmed from the information provided but may be the result of instability or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.

• Brand Name: TRULIANT TIB IMP CR INS SLOPE++ SZ 2 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20138719
• Report Number: 1038671-2024-03283
• Device Sequence Number: 15303390
• Product Code: JWH
• UDI-Device Identifier: 10885862307101
• UDI-Public: 10885862307101
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2026
• Device Catalogue Number: 02-022-49-2011
• 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: 01/03/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female