MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-5011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case ¿ usa (mdl no.(b)(4)) (ngg) (mmh) it was reported via legal documentation that approximately 125 months after a left total knee replacement procedure, the patient has experienced prosthesis wear.No further issues or complications were reported.No additional information is available.Initial ebi surgery unable to be found.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.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.G4: corrected.H6: corrected health effect and investigation clinical codes.
Additional Manufacturer Narrative
A1-3: added patient dob and gender.B-5: updated description summary.D-4: added serial number, catalogue number, udi and expiration date.D-10: changed unk to see h11.H-4: added manufacture date.H-6: added clinical code 1870.H11: added concomitants.(b)(6) 02-010-01-0250 - logic femoral ps cem left sz 5.(b)(6) 02-012-41-5050 - logic tibia traptray cem sz 5f/5t.(b)(6) 200-02-35 - three peg patella 35mm.
Event or Problem Description
It was reported via legal documentation that approximately 125 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, osteolysis, synovitis, loosening of femoral and tibial tray, intraoperative fracture of femur.His left knee had become extremely painful, and he has gone on to have massive osteolysis in the distal femur and proximal tibia with loosening.He was indicated for a semi urgent revision knee replacement.Upon making arthrotomy, there was evidence of massive synovitis with osteolytic tissue.The polyethylene was removed.There was evidence of bone loss on the tibia and the femur.Both the femur and the tibia were loose, but not grossly loose.Upon removing the femur, there was massive osteolysis with a giant cavitary defect with almost no condyles, just axial condyle.While trailing, the attention from the construct caused a fracture of the medial femoral condyle given how poor his bone quality was.No other issues or complications were reported.The patient was brought to the recovery room in stable condition.No additional information is available.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20153317
• Report Number: 1038671-2024-03333
• Device Sequence Number: 20908437
• Product Code: JWH
• UDI-Device Identifier: 10885862173720
• UDI-Public: 10885862173720
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• 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,Followup,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: 03/26/2016
• Device Catalogue Number: 02-012-44-5011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: Not provided; 12/11/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 11/21/2024; 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2011
• 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.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male