MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0335
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices (b)(6) 02-012-35-3509 - logic tibia ps mod insrt sz 3.5 9mm.(b)(6) 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t.(b)(6) 02-010-01-0235 - logic femoral ps cem left sz 3.5.(b)(6) 200-02-32 - three peg patella 32mm.(b)(6) 200-02-32 - three peg patella 32mm.(b)(6) 201-78-89 - 3" drill bit, mod.Hex 2 pack.(b)(6) 203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19.(b)(6) 1500-s - cemex system 80g.(b)(6) asa0030 - sterile disposable containers.(b)(6) asa0030 - sterile disposable containers.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case: usa.Related case (b)(4) lk rev.As reported via legal documentation the patient had a right knee replacement on (b)(6) 2014.Approximately 8 years and 5 months after the initial procedure the patient had a right knee revision on (b)(6) 2022.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.Revision op report on 21 nov 2022.Principal diagnosis: failed right total knee replacement due to mechanical loosening.Post-op diagnosis: same.Significant fibrinous debris was encountered into the joint with a tandem whitish color this tissue was highly friable was found throughout the suprapatellar pouch as well as in the gutters.This was excised and the knee in order to fully debrided to visualize all the components then removes similar debris from the anterior interval as well as did are normal medial release.We then removed the polyethylene insert with a single prong retractor.The poly was noted to be yellow with significant pitting and loss of thickness in the medial lateral compartment with central pitting and roughness noted on both the medial and lateral dwell points.The femoral implant was grossly loose and was removed without any machine and.Similar fibrous debris was found under the femoral component and into the posterior lateral.This was debrided with sharp dissection as well as with the rongeur bluntly.No device return anticipated due to this being a legal case.Ebi initial surgery attached.Operative report from revision surgery attached.No further information.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 3.5
• 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 ; 3523771140
• MDR Report Key: 20569557
• Report Number: 1038671-2024-04184
• Device Sequence Number: 7225223
• Product Code: JWH
• UDI-Device Identifier: 10885862001245
• UDI-Public: 10885862001245
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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: 01/30/2019
• Device Catalogue Number: 02-010-01-0335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 10/30/2024
• Date Device Manufactured: 01/31/2014
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male