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

Catalog Number	02-012-44-2009
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 112 months after a left total knee replacement procedure, the patient has experienced prosthesis wear destruction of bone, osseous resorption, osteolysis, synovitis, swelling, pain, limited rang eof motion, difficulty walking, and loss of enjoyment of life.No further issues or complications were reported.No additional information is available.Right knee also operated in (b)(4).
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
1038671-2024-03144 d10 concomitant devices: (b)(6) 02-010-01-0220 - logic femoral ps cem left sz 2.N/a 02-012-41-2010 or 2020 - logic tibia traptray cem sz 2f/1t or sz 2f/2t.N/a 200-02-29 or 32 - three peg patella 29mm or 32mm.D4 pn: 02-012-44-2009 - logic tibia implant psc insert, sz 2, 9mm.Serial: (b)(6).Udi: (b)(4).G4 510k: k110547.H4 manufacturing date 24nov2014.H6: corrected the following: health effect - clinical code, medical device problem 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, and/or loss of range of motion, 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: added the following: health effect - medical device problem code.

• 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 ; 3523771140
• MDR Report Key: 19425620
• Report Number: 1038671-2024-01592
• Device Sequence Number: 15430103
• Product Code: JWH
• UDI-Device Identifier: 10885862173478
• UDI-Public: 10885862173478
• 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: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,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
• Device Expiration Date: 11/21/2022
• Device Catalogue Number: 02-012-44-2009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: Not provided; 10/30/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 10/31/2024; 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2014
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female