MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 3, 9MM, SLOPE ++; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	CR TIBIAL INSERT SZ 3, 9MM, SLOPE ++
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10:concomitants: 200-04-34 - cemented finned tib.Tra sz 3f/4t 1544933.200-05-26 - inset patella 26mm 2347352.230-03-03 - optetrak asy,cr cemented femoral, sz 3, 2255369.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that an 82 yo male patient, who had bilateral knee replacements and was implanted with recalled poly, presented to the surgeon¿s office with complaints of pain, swelling, instability and dissatisfaction with both their tka¿s.The left knee hurt more than the right at this time however, the surgeon noted on the x-ray that the right knee looked worse with poly wear and possible loosening of the implants.The initial right knee replacement occurred on (b)(6) 2012.No revision of the right knee has occurred currently.X-ray provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3: the revision reported was likely due to pain and instability, or due to the packaging recall of the polyethylene.Instability may be the result of increased soft-tissue laxity (looseness), inadequate flexion of the implants, or improper positioning or alignment of the prosthesis.Prosthesis wear of the polyethylene components and loosening could not be confirmed and as images of the explanted devices were not provided.H6 clinical, component, and investigation codes added.H10: the following sections were corrected: h6: component code 4756 no longer applies.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The incident reported was likely due to pain and instability, or due to the packaging recall of the polyethylene.Instability may be the result of increased soft-tissue laxity (looseness), inadequate flexion of the implants, or improper positioning or alignment of the prosthesis.Prosthesis wear of the polyethylene components and loosening could not be confirmed and as images of the explanted devices 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 3, 9MM, SLOPE ++
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17631642
• Report Number: 1038671-2023-02062
• Device Sequence Number: 6492194
• Product Code: JWH
• UDI-Device Identifier: 10885862041258
• UDI-Public: 10885862041258
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K082022
• 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
• Report Date (Section B): 07/10/2025

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: 01/05/2014
• Device Model Number: CR TIBIAL INSERT SZ 3, 9MM, SLOPE ++
• Device Catalogue Number: 200-73-09
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 06/24/2025; 07/09/2025
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 06/25/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2009
• 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: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 100 KG