MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 15MM; SEE H10

Model Number	204-23-15
Medical Device Problem Codes	Material Integrity Problem (2978); Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Unspecified Infection (1930); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Joint Laxity (4526); Metal Related Pathology (4530)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procodes: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: 8850323 208-01-03 - cc femoral sz 3.Pending investigation.
Event or Problem Description
It was reported from the legal department that on (b)(6) 2018, a patient underwent a second revision of the left exactech knee device secondary to polyethylene liner wear, approximately 6 years 4 months after the first revision.It is stated that despite undergoing the revision surgeries, the patient experiences daily knee pain and discomfort which limit activities of daily living and recreation and impacts quality of life.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, impact code, problem code, component 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 and loosening or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear 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 3, 15MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16640217
• Report Number: 1038671-2023-00544
• Device Sequence Number: 17477895
• 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: 2012
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2018
• Device Model Number: 204-23-15
• Device Catalogue Number: 204-23-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2010
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female