MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ3, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	CR TIBIAL INSERT SZ3, 15MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this 66 y/o male patient had both right and left primary cr tka's done in 2012.The patient presented to surgeon's office originally for his right knee, having pain, swelling, and stiffness.Surgeon performed a right total knee revision tka on the patient.The patient had evident osteolysis and poly wear on the x-ray.The date of the right knee revision was not given.The surgeon said that the original poly was destroyed when removed and the patient had substantial lysis in the tissues and bones.The right knee tibia implant was loose and so he revised the primary tka to a revision tka of another company.The patient presents to be doing well post right knee total revision.The devices are not available for evaluation.
Additional Manufacturer Narrative
Concomitant medical products: cemented cr femoral sz 3 (cat#: 200-01-03/serial#: (b)(4).Cemented finned tib.Tra sz 3f/4t (cat#: 200-04-34/serial#: (b)(4).Inset patella 26mm (cat#: 200-05-26/serial#: (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Section d10: concomitant medical products: cemented cr femoral sz 3 (cat# 200-01-03/serial# (b)(6)).Cemented finned tib.Tra sz 3f/3t (cat# 200-04-33/serial# (b)(6)).Inset patella 26mm (cat# 200-05-26/serial# (b)(6)).
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 was likely the result of prosthesis wear of the tibial insert, osteolysis, and tibial loosening.The wear may have been due to a combination of third body wear, positioning of the components, instability, and/or patient related conditions.The reported aseptic (non-infected) tibial loosening/osteolysis may have been due to an insufficient bond between the tibial tray and the bone.However, this cannot be confirmed as the components were not returned for evaluation and images/radiographs were not provided.It is unclear if the reported loosening may have contributed to the wear or if the wear may have contributed to the reported loosening.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.Also, the most probable root cause associated with the reported event of ¿osteolysis¿ is associated with destruction or disappearance of bone tissue likely related to weakened integration of an implant at the bone-implant interface.Furthermore, the most probable root cause associated with the event of ¿loosening- tibial¿ associated with weakened integration of the tibial component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b3 (remove erroneous date from initial report- date of event unknown), d6a, d8, e4 (remove erroneous entry form initial report), h6: clinical codes, component code, investigation findings and investigation conclusions., h10, h11.H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2026-00297.The revision reported was likely the result of prosthesis wear of the tibial insert, osteolysis, and tibial loosening.The wear may have been due to a combination of third body wear, positioning of the components, instability, and/or patient related conditions.The reported aseptic (non-infected) tibial loosening/osteolysis may have been due to an insufficient bond between the tibial tray and the bone.However, this cannot be confirmed as the components were not returned for evaluation and images/radiographs were not provided.It is unclear if the reported loosening may have contributed to the wear or if the wear may have contributed to the reported loosening.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 SZ3, 15MM
• 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: ashley harris ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15633441
• Report Number: 1038671-2022-01334
• Device Sequence Number: 20283043
• Product Code: JWH
• UDI-Device Identifier: 10885862040275
• UDI-Public: 10885862040275
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2018
• Device Model Number: CR TIBIAL INSERT SZ3, 15MM
• Device Catalogue Number: 200-23-15
• 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: 09/30/2022
• Supplement Date Received by Manufacturer: 05/10/2023; 06/22/2023; 03/12/2026
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 06/07/2023; 07/20/2023; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 107 KG