MAUDE Adverse Event Report: EXACTECH, INC. KNEE IMPLANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-60-1425
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 48 months after a left knee replacement procedure, the patient underwent a revision procedure to prosthesis wear.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: concomitant devices unknown.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
D4: corrected d10: concomitant devices (b)(6) , 02-022-44-4012 - truliant tib imp psc insert sz 4, 12mm.(b)(6) , 02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t.(b)(6) , 204-70-00 - tibial stem ext.Screw.(b)(6) , 02-020-11-0240 - truliant ps cem fem ps cem left sz 4.(b)(6) , 02-012-60-1425 - tru stem ext 14mm x 25mm.(b)(6) , 200-02-38 - three peg patella 38mm.

• Brand Name: KNEE IMPLANT
• 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: 20146786
• Report Number: 1038671-2024-03318
• Device Sequence Number: 8397433
• Product Code: JWH
• UDI-Device Identifier: 10885862272102
• UDI-Public: 10885862272102
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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,Followup
• Report Date (Section B): 10/08/2024

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: 10/30/2024
• Device Catalogue Number: 02-012-60-1425
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 11/03/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown