MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 3, 11MM, SLOPE ++; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CR TIBIAL INSERT SZ 3, 11MM, SLOPE ++
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: - cemented finned tib.Tra sz 3f/3t (cat# 200-04-33 / serial# (b)(6).- inset patella 26mm (cat# 200-05-26 / serial# (b)(6) - optetrak asy,cr cemented femoral, sz 3 (cat# 230-02-03 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 79 yo female patient, initial left total knee implanted on (b)(6) 2013, underwent a revision procedure on (b)(6) 2024, approximately 10 years 10 months post the initial procedure.The patient returned to the surgeon¿s office with complaints of pain, swelling, instability, and dissatisfaction with their tka.The patient has a recalled poly implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs full revision.The patient had revision surgery on (b)(6) 2024.The patient underwent a full knee revision to a competitor¿s product.The poly showed some oxidation and delamination.The patella was loose and came off the patella bone.The femoral component was loose and was removed from the bone.The tibia implant was removed from the bone.There were no device breakages during the procedure.There was a 30-45 minute surgical delay during the procedure with no adverse events to the patient as a result.No x-rays were provided.The patient was last known to be in stable condition following the event.No explanted devices are available for return.They were sent to the lab and legal at the hospital.Device images were provided.No further information.
Additional Manufacturer Narrative
D4: corrected h6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: CR TIBIAL INSERT SZ 3, 11MM, SLOPE ++
• 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 ; gainesville 32653
• MDR Report Key: 19112474
• Report Number: 1038671-2024-00856
• Device Sequence Number: 18055259
• Product Code: JWH
• UDI-Device Identifier: 10885862041265
• UDI-Public: 10885862041265
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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: 12/07/2019
• Device Model Number: CR TIBIAL INSERT SZ 3, 11MM, SLOPE ++
• Device Catalogue Number: 200-73-11
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2011
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 61 KG