MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT CR CEM FEM CR CEM RIGHT SZ 2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-020-13-0325
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: 02-022-51-2513, truliant tib imp crc insert sz 2.5, 13mm (b)(4), (b)(4), the serial number (b)(4) is not affected by the recall.Serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.02-012-50-1511, logic fit/rbk augment 1/2 block sz 1.5, 5mm, 5957621, 5957629, 02-012-60-1440, logic stem ext 14mm x 40mm, 6512894, 02-012-61-6000, logic offset stem ext coupler 6mm, 6124386, 02-022-45-2515, truliant tib fit tray cem sz 2.5f / 1.5t, 6219593, 6289224, 201-78-15, holding pin mini sharp point 4 pk, 6579209, 201-78-98, 2 pk, schanz pin, 4mm x 130mm, 6635668, 204-34-02, fluted stem extension 25l x 14 mm, 6485326, 204-70-00, tibial stem ext.Screw, 6506819, 6579957, 521-78-23, threaded pin size 2.3 collared 2pk, s049399, 521-78-32, threaded pin size 3.0 collarless 2pk, s047783, s049508, a10012, gps implant kit v2, 03008520222.
Event or Problem Description
It was reported that this 58 y/o female patient's right knee was revised.Reason for the revision was not reported.Devices are not returning.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of an insufficient bond between the implants and the bone, patient-related conditions, or a combination of the two, which led to aseptic (non-infected) loosening.However, this cannot be confirmed as the devices were not available for evaluation and pre-revision radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5, h6, h11 the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from an insufficient bond between the implants and the bone, patient-related conditions, or a combination of the two, which led to aseptic (non-infected) loosening.However, this cannot be confirmed as the devices were not available for evaluation and pre-revision 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.
Event or Problem Description
As reported, approximately 2 years post the initial right total knee arthroplasty, the patient was revised due to loosening.No further information provided.

• Brand Name: TRULIANT CR CEM FEM CR CEM RIGHT SZ 2.5
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15761693
• Report Number: 1038671-2022-01436
• Device Sequence Number: 15515309
• Product Code: JWH
• UDI-Device Identifier: 10885862315311
• UDI-Public: 10885862315311
• 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: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2026

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: 02-020-13-0325
• Device Catalogue Number: 02-020-13-0325
• 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: 10/20/2022
• Supplement Date Received by Manufacturer: 03/24/2023; 04/15/2026
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 04/14/2023; 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female