MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-47-5013
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Joint effusion (4849)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 6110294, 02-012-60-1440 - tru stem ext 14mm x 40mm.6721808, 02-020-13-0250 - truliant cr cem fem cr cem left sz 5.6818540, 02-022-45-5050 - truliant tib fit tray cem sz 5f / 5t.6870038, 200-02-38 - three peg patella 38mm.6827049, 204-70-00 - tibial stem ext.Screw.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6) 2021.Over the next several months, the patient underwent physical therapy sessions and follow up appointments with the surgeon, as well as injections to his left knee.Approximately 10 months after the initial procedure the patient had a left knee revision on (b)(6) 2022 to remove the polyethylene, causing the injuries and damages complained of.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2022.Diagnosis: painful left total knee, polyethylene wear.At the time of surgery there was some minor wear of the polyethylene on both the lateral and medial tibial surfaces with some more significant wear along the posterior medial corner of the polyethylene.The femoral and tibial components were intact.The 13mm polyethylene was exchanged for a new 15 mm polyethylene and the knee showed excellent range of motion and stability.The patient was also noted to have heavy scar tissue throughout the joint capsule.The scar tissue was debrided along the suprapatellar pouch and medial and lateral gutters.The patient was taken to recovery room in stable condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be determined from the available information but may have been reported at this later time due to inclusion of one of the implanted devices in the packaging recall.Based on length of implantation, the reason for revision appears unlikely to be secondary to prosthesis wear.However, the reported prosthesis wear/failure, and loss of range of motion could not be confirmed and potential contributions of user, or patient-related considerations to the event could not be assessed as no images or radiographs were provided, relevant clinical information was not provided, and the devices were not available for evaluation.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 CR INS STD SZ 5, 13MM
• 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: kate jacobson
• MDR Report Key: 17958175
• Report Number: 1038671-2023-02552
• Device Sequence Number: 12086044
• Product Code: JWH
• UDI-Device Identifier: 10885862306593
• UDI-Public: 10885862306593
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2024
• Device Catalogue Number: 02-022-47-5013
• 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: 08/14/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• 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
• Patient Age: 58 YR
• Patient Sex: Male