MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 4F / 4T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-4040
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: (b)(6) 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t.(b)(6) 02-010-03-0340 - logic cr femoral cem, right, sz 4.(b)(6) 200-02-32 - three peg patella 32mm.The product associated with the reported event is within the scope of recall however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.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.Patient id: (b)(6).This patient has a verified right knee replacement on the master list with (b)(6).No device return anticipated due to this being a legal case.Ebi initial surgery attached.Historical record & smartsolve searched for sn/patient name with no results.Operative report from revision surgery attached.No further information.Serial number item number and full description: (b)(6) 02-012-49-4013 - logic cr tib insert slope++, sz 4, 13mm.***serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510(k): k111400.Concomitants: (b)(6) 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t.(b)(6) 02-010-03-0340 - logic cr femoral cem, right, sz 4.(b)(6) 200-02-32 - three peg patella 32mm.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, impact code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusions.The reason the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral loosening, tibial loosening and/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.
Additional Manufacturer Narrative
H6: corrected the following: medical device problem code, component code, type of investigation.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral loosening, tibial loosening and/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.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 4F / 4T
• 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20138479
• Report Number: 1038671-2024-03281
• Device Sequence Number: 15323974
• Product Code: JWH
• UDI-Device Identifier: 10885862004024
• UDI-Public: 10885862004024
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2024

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 Catalogue Number: 02-012-45-4040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: Not provided; 10/30/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/31/2024; 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 76 YR
• Patient Sex: Male