MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-24-09
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Loss of Range of Motion (2032); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint effusion (4849)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 115 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, osteolysis, aseptic loosening, knee pain, swelling, joint effusion, bone loss, difficulty walking, and limited range of motion.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10 concomitant devices: 2012977 234-03-04 - optetrak asy,ps cemented femoral, sz 4.2859734 204-04-43 - trapezoid tibial tray sz 4f/3t.2877683 200-02-29 - three peg patella 29mm.The product associated with this report 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 report 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 of contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filled accordingly.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, medical device problem code, type of investigation, investigation findings, investigation conclusions the reason the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, range of motion, and loosening or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear, range of motion, and loosening 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: PS TIBIAL INSERTS SZ 4, 9MM
• 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: 19392095
• Report Number: 1038671-2024-01403
• Device Sequence Number: 20776434
• Product Code: JWH
• UDI-Device Identifier: 10885862048387
• UDI-Public: 10885862048387
• 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: 2014
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: 10/22/2020
• Device Catalogue Number: 204-24-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2012
• 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