MAUDE Adverse Event Report: EXACTECH, INC. LOGIC; CC TIB INSERT SIZE 2, 15MM

Catalog Number	02-012-65-2015
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported this 64 y/o female¿s right knee was revised due to aseptic loosening of the femoral component.The initial rtk procedure was on (b)(6) 2010.Revision was done on (b)(4) 2019, during which the femoral component was revised to a cc femoral component; psc tibial insert; and 32mm patella.Parts were retrieved for return.The patient left the or in stable condition.Patient was last known to be in stable condition following the event.Patient has medical history of obesity.The tibial tray (cn: 02-012-41-2020, sn: (b)(4)) was well-fixed at the time of the revision and therefore not revised.All available information has been receive at this time.
Event or Problem Description
As reported this 64 y/o female¿s right knee was initially implanted during a rtk procedure on (b)(6) 2010.The patient was revised for an infection over a year ago and has been experiencing very limited range of motion and had roughly a 20-degree flexion contracture and barely 30 degrees of flexion.The surgery operated not sure what the issue was but was thinking poor physical therapy which resulted in significant scar tissue.As was expected, there was a lot of scar tissue removed and a larger cck insert was used (from a 15mm to a 17mm).Surgeon was thrilled about the range of motion achieved post-operatively.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the range of motion and subsequent revision cannot be conclusively determined since the devices were not returned; however, it is most likely is related to patient conditions.
Additional Manufacturer Narrative
The evaluation noted that as reported this 64 y/o female¿s right knee was initially implanted during a rtk procedure on (b)(6) 2010.The patient was revised for an infection over a year ago and has been experiencing very limited range of motion and had roughly a 20-degree flexion contracture and barely 30 degrees of flexion.The surgery operated not sure what the issue was but was thinking poor physical therapy which resulted in significant scar tissue.As was expected, there was a lot of scar tissue removed and a larger cck insert was used (from a 15mm to a 17mm).Surgeon was thrilled about the range of motion achieved post-operatively.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the range of motion and subsequent revision cannot be conclusively determined since the devices were not returned; however, it is most likely is related to patient conditions.

• Brand Name: LOGIC
• Common Device Name: CC TIB INSERT SIZE 2, 15MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9519536
• Report Number: 1038671-2019-00624
• Device Sequence Number: 458957
• Product Code: JWH
• UDI-Device Identifier: 10885862265890
• UDI-Public: 10885862265890
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 10/11/2024
• Device Catalogue Number: 02-012-65-2015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention