MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-51-3009
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994); Scar Tissue (2060); Numbness (2415); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: 03009021137 a10012 - gps implant kit v2 west, cynthia.5681453 02-020-14-0330 - truliant cr por fem cr por right sz 3 west, cynthia.6737458 201-78-98 - 2 pk, schanz pin, 4mm x 130mm west, cynthia.6841260 02-022-55-3020 - truliant por tib tray size 3f/2t west, cynthia.6907733 201-78-15 - holding pin mini sharp point 4 pk west, cynthia.S265322 521-78-32 - threaded pin size 3.0 collarless 2pk west, cynthia.S265534 521-78-32 - threaded pin size 3.0 collarless 2pk west, cynthia.S265576 521-78-23 - threaded pin size 2.3 collared 2pk west, cynthia.H3: the revision reported was likely the result of prosthesis wear of the tibial insert.The cause of prosthesis wear is generally a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.
Event or Problem Description
It was reported via legal documentation that a patient had a right knee replacement procedure on (b)(6) 2021 and then was revised on (b)(6) 2023.Patient required revision surgery for issues including but not limited to pain, swelling, scarring, numbness, inflammation, knee popping and clicking, instability, difficulty with activities of daily living.The mostly likely cause for the revision reported due to prosthesis wear is a combination of risk factors including use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: b1, b2, h6.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and 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, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
Concomitant devices: (b)(6) a10012 - gps implant kit v2; (b)(6) 02-020-14-0330 - truliant cr por fem cr por right sz 3; (b)(6) 201-78-98 - 2 pk, schanz pin, 4mm x 130mm; (b)(6) 02-022-55-3020 - truliant por tib tray size 3f/2t; (b)(6) 201-78-15 - holding pin mini sharp point 4 p; (b)(6) 521-78-32 - threaded pin size 3.0 collarless 2pk; (b)(6) 521-78-32 - threaded pin size 3.0 collarless 2pk; (b)(6) 521-78-23 - threaded pin size 2.3 collared 2pk.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and 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, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 3, 9MM
• 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: 19197057
• Report Number: 1038671-2024-00998
• Device Sequence Number: 12672673
• Product Code: JWH
• UDI-Device Identifier: 10885862307637
• UDI-Public: 10885862307637
• 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: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2024

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 Catalogue Number: 02-022-51-3009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 11/22/2024; 11/22/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 11/26/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0023-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown