MAUDE Adverse Event Report: EXACTECH, INC. TRU CC TIB INSERT SIZE 5, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-5015
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 02-010-06-0350 - tru cc femoral size 5 right, (b)(6), 02-010-06-0551 - tru post.Aug.Size 5, 5mm, (b)(6), 02-010-06-0551 - tru post.Aug.Size 5, 5mm, (b)(6), 02-010-06-0552 - tru post.Aug.Size 5, 10mm, (b)(6), 204-34-16 - stem extension w/slot 160l x14 mm, (b)(6), 208-10-15 - cc femoral aug screw 15mm.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The 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 definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was 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
It is reported via legal notification approximately 24 months after a right knee revision surgery, the patient has experienced pain in his right knee.No surgical or medical interventions were reported.No additional information is available.The serial number (b)(6) is confirmed to be a part of recall number: z-0021-2022.02-012-65-5015 - logic cc tib insert size 5, 15mm serial: (b)(6), 510k: k150890, udi: (b)(4), product code: jwh, x-ray: no, operative notes: no.Concomitant devices:.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Corrected h6 health effect clinical code.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.B3: date of event is unknown.D6b: explant date is unknown.The pain and prosthesis wear reported cannot be confirmed as the devises have not been revised.The reason for the legal filing may have been due to the inclusion of the polyethylene in the packaging recall.Potential contributions of user or patient-related considerations could not be assessed as the devices remain implanted and no images, radiographs, or relevant clinical information was provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRU CC TIB INSERT SIZE 5, 15MM
• 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
• MDR Report Key: 21453811
• Report Number: 1038671-2025-01172
• Device Sequence Number: 7320471
• Product Code: JWH
• UDI-Device Identifier: 10885862613592
• UDI-Public: 10885862613592
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2023
• Device Catalogue Number: 02-012-65-5015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 03/17/2025; 04/17/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 04/15/2025; 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2015
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male