MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-3009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation this patient had initial right knee arthroplasty on (b)(6) 2014 and then later experienced right knee revision 9 years, 1 month later.Patient revised to competitor¿s devices.Revision operative report of (b)(6) 2023- pre-op diagnosis: failed right total knee replacement.Procedure: 1) revision right total knee arthroplasty (tibial and femoral implants).Patient is morbidly obese with a bmi of 44; this required additional operative time.Intraoperative findings: loose femoral and tibial implants - removed easily with severe bone loss - required femoral and tibial cones.The lateral femoral condyle bone loss was severe - an area of bone along the distal femoral condyle the size of a ping-pong ball was destroyed as a result of polyethylene wear.This appeared to be osteolysis.This required a cone for fixation as well as a cck locking liner.There was extensive soft tissue debris throughout the knee joint consistent with a synovitis from a polyethylene reaction to the tissues.This was tiny, small balls of light brown / white synovium along with a "pseudo-capsule" of dense soft tissue rind.The total amount of soft tissue damage that required resection was enough soft tissue to fill ~ 24 oz can size.Polyethylene - excessive wear was present with signs of oxidation / yellow discoloration, pitting, cracking, and delamination of the poly.Distal femoral bone loss was.This did require a femoral cone.The tibial bone loss was extensive and required placement of a tibial cone.There were no intraoperative complications, patient was stable and transferred to the pacu.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 other information is available.
Additional Manufacturer Narrative
D10.Concomitants: (b)(6); 02-010-01-0330 - logic femoral ps cem right sz 3/ (b)(6); 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t (b)(6); 200-02-32 - three peg patella 32mm.These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.
Additional Manufacturer Narrative
Recall number: z-0021-2022 1038671-2024-04764, 1038671-2024-04762 this follow-up report is being submitted to relay additional and/or corrected information.D10: concomitants: (b)(6) 02-010-01-0330 - logic femoral ps cem right sz 3.(b)(6) 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.(b)(6) 200-02-32 - three peg patella 32mm.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-04764, 1038671-2024-04762.The following sections were updated: g1, h6.The following sections were corrected: b2, g1, h6.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral loosening, and tibial loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user 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 TIBIA IMPLANT PSC INSERT, SZ 3, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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 ct; gainesville, FL 32653
• MDR Report Key: 18022964
• Report Number: 1038671-2023-02620
• Device Sequence Number: 7585538
• Product Code: JWH
• UDI-Device Identifier: 10885862173553
• UDI-Public: 10885862173553
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• 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): 12/11/2024

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: 07/24/2022
• Device Catalogue Number: 02-012-44-3009
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2014
• 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: 55 YR
• Patient Sex: Female