MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 1, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CR TIBIAL INSERT SZ 1, 9MM
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	11/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, surgeon was struggling to implant our poly.Poly entire medial articulation surface was delaminated and posterior portion was missing.Femur, the cobalt chrome finish was scratched due to articulation with the metal of the tibia.Tibia, the posteromedial portion was absent, likely due to dislodgement from the posterior femur.Surgeon decided to do a full two component revision with competitor's device.There were no images captured.The device is not available for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported may have been the result of wear of the tibial insert.The cause of the wear could not be determined but may have been due to third body wear, orientation of the components, patient-related conditions, or any combination of these possibilities.The posterior wear likely led to metal-on-metal contact between the femoral component and tibial tray which resulted in the reported scratches of the femoral component, remolding of the posterior portion of the tibial tray, and metallosis.However, this cannot be confirmed because the devices were not returned for evaluation and images/pre-revision radiographs were not provided.The most probable root cause associated with the reported event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
Corrected information: a2, b2, d8, g, g2, h6.
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 fracture 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: CR TIBIAL INSERT SZ 1, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15874908
• Report Number: 1038671-2022-01523
• Device Sequence Number: 5398855
• Product Code: JWH
• UDI-Device Identifier: 10885862040145
• UDI-Public: 10885862040145
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/25/2025

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 Expiration Date: 03/22/2018
• Device Model Number: CR TIBIAL INSERT SZ 1, 9MM
• Device Catalogue Number: 200-21-09
• 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: 11/10/2022
• Supplement Date Received by Manufacturer: 05/12/2023; 12/12/2024; 04/24/2025
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 06/13/2023; 12/31/2024; 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2010
• 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-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACCELERATE CONC. SYS REP BY; CEMENTED CR FEMORAL SZ 1D, 1; CEMENTED FINNED TIB. TRA SZ 2F/1T; CEMEX SYSTEM FAST 70 GM; PLATELET RICH PLASMA KIT WITH SPRAY TIPS; THREE PEG PATELLA 29MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female