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 Code	Failure of Implant (1924)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: 02-012-65-2017, 4859399 - logic cc tib insert size 2, 17mm; 208-06-02, 6609320 - cc distal fem augment sz 2, 10mm; 02-010-06-0521, 6076644 - logic post.Aug.Block size 2, 5mm; 208-05-02, 6174918 - cc distal fem augment sz 2, 5mm; 02-012-61-6000, 5688040 - logic offset stem ext coupler 6mm; 02-012-60-1680, 6063735 - logic stem ext 16mm x 80mm; 02-012-65-2015, 5119395 - logic cc tib insert size 2, 15mm.Additional information, including the product investigation, will be submitted within 30 days of rec.
Event or Problem Description
As reported, approximately 6 yrs postop the ltka, this (b)(6) y/o female patient presented complaining of knee pain in their revised left knee.Femoral loosening and misalignment were noted, and the patient was scheduled for a femoral revision.The femoral component was removed and replaced with a logic cc component with various augments etc.The tibial component was well fixed and was not removed.The optetrak femoral component and insert were removed and replaced with logic cc components.During trialing a 15mm insert was deemed appropriate.After insertion of the tibial insert the surgeon opted to go up to a 17mm insert wasting the 25.Patient was last known to be in stable condition following the event.Devices not returning due to facility policy.
Additional Manufacturer Narrative
After further review the following sections d1, d4, d10, g4 and h4 have been corrected accordingly.Section d10: concomitant medical products: cc posterior femoral augment, sz 2, 5mm (cat# 208-07-02 / serial# (b)(6)); cc posterior femoral augment, sz 2, 5mm (cat# 208-07-02 / serial# (b)(6)); cc distal femoral augment, sz 2, 10mm (cat# 208-06-02 / serial# (b)(6)); cc distal femoral augment, sz 2, 5mm (cat# 208-05-02 / serial# (b)(6)); cc distal femoral augment, sz 2, 5mm (cat# 208-05-02 / serial# (b)(6)); adapter stem screw (cat# 208-09-05 / serial# (b)(6)); fluted stem extension, 120l x 14mm (cat# 204-34-12 / serial# (b)(6)); optetrak cc tibial insert and screw, sz 2, 11mm (cat# 208-22-11 / serial# (b)(6)).
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of poor femoral bone quality, malpositioning of the femoral components, and femoral loosening.However, the underlying cause of the malpositioning and loosening cannot be confirmed because the devices were not returned for evaluation.The most probable root cause associated with the reported event of "loosening - femoral" is associated with weakened integration of the femoral component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.Also, a probable root cause associated with the reported event of ¿migration¿ is a problem with all or part of an implanted or invasive device moving from its intended location within the body.Furthermore, another probable root cause associated with the reported event of ¿patient conditions¿ that is associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.

• 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: 12329319
• Report Number: 1038671-2021-00389
• Device Sequence Number: 14159516
• Product Code: JWH
• UDI-Device Identifier: 10885862265654
• UDI-Public: 10885862265654
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2022

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: 07/15/2020
• 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: 07/27/2021
• Supplement Date Received by Manufacturer: 01/12/2022; 01/14/2022
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 01/12/2022; 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• 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: Disability; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 46 KG