MAUDE Adverse Event Report: EXACTECH, INC.; SEE H10

Catalog Number	02-012-44-4013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal notification, that patient, underwent initial right total knee replacement and was implanted with an exactech optetrak comprehensive total knee replacement on (b)(6) 2016.On or about (b)(6) 2022, approximately 6 years 4 months post initial procedure, plaintiff underwent a revision surgery on his right knee for issues including but not limited to polyethylene wear, bone loss, osteolysis, instability, and/or component loosening.The operative report for plaintiff¿s revision knee replacement notes that ¿there was very extensive synovitis,¿ ¿there was noted to be wear of the [polyethylene] liner,¿ and ¿the femoral component was noted to be loose.There was significant fibrous tissue beneath it with some osteolysis,¿ among other issues.Additionally, the revision pathology report noted ¿the synovial and capsular tissue fragments are expanded by a mononuclear and giant cell reaction to a mixture of large and small particles of refractile material consistent with polyethylene debris.¿ plaintiff¿s medical records reflect the typical findings of accelerated and preventable polyethylene wear due to defective design of the device and a manufacturing defect of the device which produced toxic polyethylene particles and debris, resulting in premature catastrophic failure and revision surgery.Plaintiff experiences daily pain and discomfort in his right knee which limits his activities of daily living and impacts his quality of life.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer,metal,polymer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
1038671-2024-04324, 1038671-2024-04321.A2: added patient age and date of birth.A3: added patient gender.D4: added catalog number, expiration date, serial number, and udi.G3: added 510k number.H4: added device manufacture date.H6: corrected health effect - clinical code, component code, type of investigation, investigation findings, and investigation conclusions.Manufacturer narrative updated: the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.

• Brand Name: UNK
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16518569
• Report Number: 1038671-2023-00404
• Device Sequence Number: 3301628
• Product Code: JWH
• UDI-Device Identifier: 10885862173652
• UDI-Public: 10885862173652
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2023
• Device Catalogue Number: 02-012-44-4013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2015
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male