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)
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.Approximately eleven years post left tka, patient presented to the surgeon's office with the start of left knee pain, stiffness, and swelling.The patient was scheduled for a revision left tka possible poly swap.The surgeon did not want the issue to persist or potentially cause more damage if there is poly wear/failure happening.The surgeon opened the knee, there was obvious lysis of the tissues and capsule.The surgeon performed a synovectomy and removed all the visibly affected tissue.The surgeon exposed the patella and it showed to be worn.The surgeon felt the patella needed to be removed and replaced.Upon removal and examination, the poly showed to be delaminated and showed pitting over the articular surface.There was some discoloration of the poly as well.There were obvious pieces that were floating in the joint.The surgeon and assistants removed all the pieces they could see and then heavily irrigated the knee joint.The surgeon then used a tamp to test and hit on the femoral and tibia components.Checking to make sure they are or are not loose.The femur and tibia components showed to be well fixed.The patient left the operating room (or) stable.The devices are available for evaluation.As of note" the patient has now had both his right and left knee revised due to poly issues and wear".
Additional Manufacturer Narrative
Concomitant medical products: cemented cr femoral sz 3 (cat# 200-01-03 / serial# (b)(4).Cemented finned tib.Tra sz 3f/3t (cat# 200-04-33 / 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 d4: serial number; expiration date, section d10: concomitant medical products (serial numbers), section h4: device manufacture date.Section d10: concomitant medical products inset patella 26mm (cat# 200-05-26 / serial# (b)(6)), cemented cr femoral sz 3 (cat# 200-01-03 / serial# (b)(6)), cemented finned tib.Tra sz 3f/3t (cat# 200-04-34 / 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 malalignment between the femoral and tibial components, instability, third body wear, patient-related conditions, or any combination of these possibilities after being implanted for over 10 years, which led to wear of the polyethylene components.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
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5 (report #1 of 2), d8, d9, e4 (remove erroneous entry from initial report), h6 clinical codes, component code, types of investigation, investigation findings and investigation conclusion., h10, h11.H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2026-00310.The revision reported was likely the result of malalignment between the femoral and tibial components, instability, third body wear, patient-related conditions, or any combination of these possibilities after being implanted for over 10 years, which led to wear of the polyethylene components.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: 15633262
• Report Number: 1038671-2022-01333
• Device Sequence Number: 5960771
• 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
• Device Explanted Year: 2022
• 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): 03/23/2026

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: 09/07/2018
• Device Model Number: CR TIBIAL INSERT SZ3, 15MM
• Device Catalogue Number: 200-23-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• 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; 07/25/2023; 03/12/2026
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 06/07/2023; 08/22/2023; 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2010
• 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: CEMENTED CR FEMORAL SZ 3; CEMENTED FINNED TIB. TRA SZ 3F/3T; SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 107 KG