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

Catalog Number	204-23-15
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that approximately 132 months after a left knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, suffered recurring pain in his left knee, crepitus sensations, weakness, swelling, pain while ambulating, soft tissue discomfort, decreased range of motion, instability, and difficulty arising from a sitting to standing position.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D4: added catalog number, expiration date, serial number, and udi d10: (b)(6) 203-96-03 - (11-2216) saw blade new stryker (.050).(b)(6) 203-96-02 - (11-2324) saw blade new stryk (.035).(b)(6) 203-96-01 - (11-2222) saw blade new stryk (.050).(b)(6) 204-32-08 - stem extension 80l x12 mm.(b)(6) 208-07-01 - cc posterior fem augment sz 1, 5mm.(b)(6) 204-34-12 - fluted stem extension 120l x 14 mm.(b)(6) 208-07-01 - cc posterior fem augment sz 1, 5mm.(b)(6) 204-70-00 - tibial stem ext.Screw.(b)(6) 208-09-05 - cc stem ext adaptor 5 degree.(b)(6) 204-04-33 - trapezoid tibial tray sz 3f/3t.(b)(6) 208-01-03 - cc femoral sz 3.G3: added 510k number.H4: added device manufacture date.H6: corrected health effect - clinical code, medical device problem code, and type of investigation.Manufacturer narrative updated: the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and range of motion or due to inclusion of the polyethylene in the packaging recall.Additionally, the devices were implanted for over ten years prior to the reported failures.However, the reported prosthesis wear, instability, and range of motion could not be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• 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: 19485070
• Report Number: 1038671-2024-01834
• Device Sequence Number: 12739138
• Product Code: JWH
• UDI-Device Identifier: 10885862048332
• UDI-Public: 10885862048332
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 10/01/2024

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 Expiration Date: 06/26/2016
• Device Catalogue Number: 204-23-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2008
• 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.; UNKNOWN.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown