MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-22-15
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitants: 200-05-23 - inset patella 23mm 2115928, 200-04-22 - cemented finned tib.Tra sz 2f/2t 2167773, 200-01-02 - cemented cr femoral sz 2 8847909.
Event or Problem Description
As reported, approximately 12 years and 10 months post initial total knee replacement (tka), the patient presented to the doctor office complaining about their tka with reports of pain, instability, and dissatisfaction.The patient had a recalled tibial poly insert.The patient was scheduled for a left full knee revision vs poly swap.The patient underwent a left knee revision, a femoral component revision and a poly revision was performed due to instability of the knee even at the thickest crc poly 19mm.The patient was revised to femoral ps- cc revision component and psc poly implant.The surgeon wanted to upsize the femur component for sizing and to close the flexion gap knowing it is off label if keeping the current tibia implant size.The tibia component was well fixed, and the surgeon trailed a psc poly implant for that size tibia.The surgery was prolonged approximately 15-30 minutes.The surgeon was happy with the articulation and stability.The patient was implanted with the revision femoral component and new psc poly.The patient left the or stable and was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3, h6 type of investigation, investigation findings, and investigation conclusions the following sections were corrected: h6 problem code.H3: the revision reported may have been the result of the reported instability or the inclusion of the polyethylene component in the packaging recall.The observed damage to the tibial insert appears consistent with overhanging bone or bone cement interacting with the lateral non-articular edges of the tibial insert rather than articular surface wear.Instability may be the result of increased soft-tissue laxity (looseness), inadequate flexion of the implants, or improper positioning or alignment of the prosthesis.

• Brand Name: CR TIBIAL INSERT SZ 2, 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 ; 3523771140
• MDR Report Key: 20568085
• Report Number: 1038671-2024-04179
• Device Sequence Number: 15318298
• Product Code: JWH
• UDI-Device Identifier: 10885862040220
• UDI-Public: 10885862040220
• 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: 2011
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 06/30/2018
• Device Catalogue Number: 200-22-15
• 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: 10/12/2024
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2010
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female