MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC TIB INSERT SIZE 4, 9MM; SEE H10

Catalog Number	02-012-65-4009
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had an initial left total knee arthroplasty on (b)(6) 2015 and then approximately 6 years 9 months later the patient had a revision surgery.Revision operative report of (b)(6) 2022 -patient was revised to competitor's devices.Postoperative diagnosis: left knee-failed constrained total knee, aseptic loosening femoral component, and osteolysis.Patient had presented with painful unstable constrained left knee.Procedure: there was extensive synovitis and a thorough synovectomy of the joint was performed.The polyethylene liner was removed and was noted to have wear and delamination.The femoral component was noted to be loose and was removed, there was marked femoral osteolysis.There was no evidence of infection.The tibial component was removed with marked osteolysis proximally.The patella component was well fixed, but there was some wear with delamination, it was removed.There was some patellar osteolysis, which was debrided.Dressings were applied and the patient was transferred to the recovery room in stable condition.The patient was to be discharged home when comfortable and met all physical therapy goals.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10.Concomitants: sn#(b)(6); cat# 02-010-06-0240 - tru cc femoral size 4 left.Sn#(b)(6); cat# 02-010-06-0541 - tru post.Aug.Size 4, 5mm.Sn#(b)(6); cat# 02-010-06-0541 - tru post.Aug.Size 4, 5mm.Sn#(b)(6)8; cat# 02-010-06-0542 - tru post.Aug.Size 4, 10mm.Sn#(b)(6); cat# 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t.Sn#(b)(6); cat# 02-012-50-3014 - tru tib aug 1/2 rl sz 3, 10mm.Sn#(b)(6); cat# 02-012-60-1480 - tru stem ext 14mm x 80mm.Sn#(b)(6); cat# 02-012-60-1612 - tru stem ext 16mm x 120mm.Sn#(b)(6); cat# 208-05-04 - cc distal fem augment sz 4, 5mm.Sn#(b)(6); cat# 208-05-04 - cc distal fem augment sz 4, 5mm.Sn#(b)(6); cat# 208-10-15 - cc femoral aug screw 15mm.These devices are used for treatment not diagnosis.No other information is available.Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, patellar loosening, and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CC TIB INSERT SIZE 4, 9MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 17754530
• Report Number: 1038671-2023-02275
• Device Sequence Number: 20499224
• Product Code: JWH
• UDI-Device Identifier: 10885862266101
• UDI-Public: 10885862266101
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• 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): 12/06/2024

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: 09/23/2023
• Device Catalogue Number: 02-012-65-4009
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male