MAUDE Adverse Event Report: EXACTECH, INC. CC FEMORAL SZ 2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CC FEMORAL SZ 2
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately five years post bilateral tka, female patient had a revision due to femoral loosening.The femur was loose due to not enough cement in the canal to hold the stem in place.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos/x-rays.The devices are not available for evaluation as they were disposed by the hospital.
Additional Manufacturer Narrative
Concomitant medical products fluted stem extension 80 x 14 mm (cat# 204-34-08 / serial# (b)(4)); fem.Stem ext.Adapter 5 deg (cat# 208-09-05 / serial# (b)(4)); cemented trapezoid tray 2f/2t (cat# 204-04-22 / serial# (b)(4)); cck tibial insert size 2, 15mm (cat# 208-22-15 / serial# (b)(4)); fluted stem extension 80 x 12 mm (cat# 204-32-08 /serial# (b)(4)); three peg patella, 32mm (cat# 200-02-32 / serial# (b)(4)); three peg patella, 32mm (cat# 200-02-32 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
(h3 the revision reported was likely the result of an insufficient bond between the implant and the bone secondary to an insufficient volume of cement as reported which led to aseptic loosening.However, this cannot be confirmed as the devices were not available for evaluation and no additional clinical information was provided.The most probable root cause associated with the reported event of "loosening - femoral¿ is associated with the loss of direct anchorage of an implanted device over time or due to an injury.

• Brand Name: CC FEMORAL SZ 2
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15620186
• Report Number: 1038671-2022-01309
• Device Sequence Number: 15008922
• Product Code: JWH
• UDI-Device Identifier: 10885862053213
• UDI-Public: 10885862053213
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2026

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: 05/11/2020
• Device Model Number: CC FEMORAL SZ 2
• Device Catalogue Number: 208-01-02
• 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: 09/28/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 05/04/2026
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 01/23/2023; 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2015
• 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