MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-3013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Discomfort (2330); Ambulation or Postural Difficulties (2544); Balance Problems (4401)
Date of Event	12/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 5834008 02-012-60-1440 - logic stem ext 14mm x 40mm.5060750 02-022-35-3013 - truliant tib imp ps insert sz 3 13mm.6378823 02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t.The product associated with the reported event is within the scope of recall z-0023-2022: however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.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
Legal case: (b)(6).Related case: (b)(4).As reported via legal documentation, on or about on (b)(6) 2020, this patient underwent revision of her right knee due to implant loosening and significant synovitis.On or about on (b)(6) 2022, approximately 2 years and 6 months after their first revision surgery, the patient underwent another revision surgery of her right knee due to mechanical failure.During the revision surgery, the surgeon noted that there was "large effusion with extensive poly wear synovitis throughout the knee" and that there was "medial tibial osteolysis with areas of bony erosion" the subsequent post-operative diagnosis confirmed that the patient's right total knee arthroplasty failed due to significant loosening, which is related to the failure in the polyethylene.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.Ebi initial surgery attached.Historical record & smartsolve searched for sn/patient name with no results.5727847 02-010-06-0330 - logic cc femoral size 3, right 510k: k150890.Concomitants: 5834008 02-012-60-1440 - logic stem ext 14mm x 40mm.5060750 02-022-35-3013 - truliant tib imp ps insert sz 3 13mm.Serial number: (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.6378823 02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3 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 court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20429036
• Report Number: 1038671-2024-03941
• Device Sequence Number: 7860740
• Product Code: JWH
• UDI-Device Identifier: 10885862304292
• UDI-Public: 10885862304292
• 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: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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: 02-022-35-3013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 10/11/2024
• 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 Sex: Unknown