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

Catalog Number	9999
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/07/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant devices 8003354 204-01-03 - ps cemented femoral sz 3 1705044 204-04-33 - trapezoid tibial tray sz 3f/3t 1793794 204-32-01 - fluted stem extension 11l x 12 mm 1767250 204-70-00 - tibial stem ext.Screw 1656853 201-78-15 - holding pin mini sharp point 4 pk 1721704 201-78-81 - 3"" trocar, mod.Hex 2pk 1721714 201-78-81 - 3"" trocar, mod.Hex 2pk 02071 203-96-03 - (11-2216) saw blade new stryker (.050) 94125 203-96-10 - (11-2325) stryker 2000 90x13mm.050"" 1.27mm 04181 203-96-21 - (11-2714) stryker 2000 90x13/21x 1.9mm the product associated with the reported event is within the scope of recall z-0019-2022; 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
It was reported that approximately 11 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
Correction: please disregard this report as it was reported in error.Event is reported under #1038671-2024-04482.

• 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 court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 19772761
• Report Number: 1038671-2024-02428
• Device Sequence Number: 18159734
• Product Code: JWH
• UDI-Device Identifier: 10885862048318
• UDI-Public: 10885862048318
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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: 04/02/2018
• Device Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2010
• 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: Hospitalization; Required Intervention
• Patient Sex: Female