MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4,; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4,
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: three peg patella 35mm (cat# 200-02-35 / serial# (b)(4)), trapezoid tibial tray sz 4f/5t (cat# 204-04-45 / serial# (b)(4)), tibial inserts sz 4, 9mm (cat# 204-24-09 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, this (b)(6) y/o female patient was revised due to femur loosening.Patella exchange due to "patella baja".There is no historical date regarding the initial implant available.The femur was loose and replaced by a cc logic offset coupler and a 18x120mm stem, with a psc insert.Patient was last known to be in stable condition following the event.The device is not available for evaluation due to implants were disposed by hospital.Additional information received indicates that bottom right corner, the metal that has embedded into the poly from the classic tibial tray where the caps for the augments sit.
Additional Manufacturer Narrative
The revision reported was most likely the result of aseptic loosening of the femoral component with possible mechanical contributions to the loosening from instability and patella baja.However, this cannot be confirmed as the devices were not available for evaluation.The most probable root cause associated with the reported event of "loosening - femoral" is associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4,
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12045831
• Report Number: 1038671-2021-00302
• Device Sequence Number: 11629144
• Product Code: JWH
• UDI-Device Identifier: 10885862063205
• UDI-Public: 10885862063205
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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: 10/16/2018
• Device Model Number: OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4,
• Device Catalogue Number: 234-02-04
• 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: 05/28/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2013
• 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
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Sex: Female