MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-11-0240
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Emotional Changes (1831); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case ¿ usa (mdl no.3044).10/8/24: additional information received in inbox on 10/7/24.Attached email, initial op report/product id, and revision op report.Revision surgery operative notes were provided.Preoperative and postoperative diagnoses indicated continued pain after left total knee arthroplasty due to malrotation over size components.Description of procedure: patient is a very pleasant 57-year-old female who underwent an index left total knee arthroplasty approximately one year ago.She came to me for evaluation of continued pain.She was worked up for periprosthetic infection, aseptic loosening, polyethylene wear, malrotation.Throughout the entire workup everything was negative but was noted that the patient had overhang of the tibial component with slight varus malalignment and most likely internal rotation of the femoral component inducing pain and lateral patellar subluxation and tilt.Once the knee was flexed up i was able to remove the polyethylene liner insert with ease.I then exposed the femur and began initially to use a quarter-inch osteotome to break the cement mantle interface.It became immediately obvious that the femur had completely debonded from the underlying cement.It was easily removed within seconds.It was noted that the patient had some mild lateral femoral condyle bone loss.I then turned my attention to the tibia and used a quarter-inch osteotome to break the cement mantle interface and then used a reciprocating saw and stacked osteotomes to remove the tibial component.It did appear better opposed to the cement and did not appear to be aseptically loose.We elected to leave the prior patellar component in place as it showed no wear.The patient was revised to a competitor¿s devices.Patient was then transferred to the pacu in stable condition.There were no apparent complications and no deviation from surgical plan.No additional information is available.It was reported via legal documentation that approximately 11 months after a left total knee replacement procedure, the patient underwent a revision procedure to address loosening; significant pain and discomfort; gait impairment; poor balance; difficulty walking; component part loosening; metallosis; soft tissue damage; infection; and other injuries presently undiagnosed, which all require ongoing medical care.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
Concomitants: (b)(6) 02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t.(b)(6) 200-02-35 - three peg patella 35mm.(b)(6) 203-96-51 - kms2212f.M62 90x13/22x1.19mm.(b)(6) 02-022-35-4009 - truliant tib imp ps insert sz 4 9mm.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.
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 confirmed from the information provided but may be the result of prosthesis wear and failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface 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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 4
• 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville 32653 ; 3523771140
• MDR Report Key: 20416696
• Report Number: 1038671-2024-03911
• Device Sequence Number: 8257528
• Product Code: JWH
• UDI-Device Identifier: 10885862314451
• UDI-Public: 10885862314451
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: 02-020-11-0240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 03/17/2025
• Date Device Manufactured: 09/11/2018
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown