MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; NMC FEMORAL SZ 3

Model Number	210-01-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): optetrak trap tibia, sz 3f/3t, optetrak cck tibial insert with ss screw, sz 3, 18mm (cat# 208-23-18), tibial stem extension, 12mm x 25mm, 3-peg patella, 35mm (cat# 200-02-35).No information provided in the following section(s): weight, ethnicity, race, implant date, udi:(serial number and expiration date), and device manufacture date.
Event or Problem Description
As reported, a (b)(6) female patient was initially implanted in 2010.A right tka revision was undertaken on (b)(6) 2019 for aseptic loosening of the right tka.After the joint was exposed, it was difficult to remove the ss screw.After several attempts, it was decided to attempt to unseat the poly insert from the tibia.Upon lifting the tibial insert off the tibial tray, it was noted that the ss screw was broken.All screw pieces were retrieved.It was moderately difficult to remove the tibial tray and residual stem extension that had half the broken screw in it.Bone loss on the femur was significant and it was then decided to revise the knee to a hinged prosthesis.It is noted that the patient reported a fall shortly after the initial procedure in 2010.Patient was last known to be in stable condition following the event.Devices are being returned to the manufacturer.All available information has been received.
Additional Manufacturer Narrative
The evaluation of the revision reported was likely the result of excessive bending loads between the femoral component and tibial insert spine that ultimately led to fatigue fracture of the screw.This likely was the result of instability in the joint that may have developed over time.The reported patient fall that occurred shortly after the index surgery could have been a contributing factor.The reported femoral loosening was likely the result of an insufficient bond between the femoral component and the bone which led to aseptic (non-infected) femoral loosening.(d11) concomitant device(s): - optetrak trap tibia, sz 3f/3t - optetrak cck tibial insert with ss screw, sz 3, 18mm (cat# 208-23-18) - tibial stem extension, 12mm x 25mm - 3-peg patella, 35mm (cat# 200-02-35).

• Brand Name: OPTETRAK
• Common Device Name: NMC FEMORAL SZ 3
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9597013
• Report Number: 1038671-2020-00006
• Device Sequence Number: 2500073
• Product Code: JWH
• UDI-Device Identifier: 10885862057402
• UDI-Public: 10885862057402
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020

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: 03/12/2015
• Device Model Number: 210-01-03
• Device Catalogue Number: 210-01-03
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR