MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; THREE PEG PATELLA 32MM

Model Number 200-02-32

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): lgc tibial fit tray cem sz 2.5f / 5t (cat# 02-012-45-2525 / sn# (b)(4)), lgc femoral ps cem right sz 2.5 (cat# 02-010-01-0325 / sn# (b)(4)), fluted stem extension 25l x 14 mm (cat# 204-34-02 / sn# (b)(4)), logic tibia implant psc insert, sz 2.5, 11mm (cat# 02-012-44-2511 / sn# (b)(4)).

Event Description

The patella was maltracking due to 2 deg to vmo weakness.

Event Description

As reported, a 79 y/o female patient¿s right knee was initially implanted (b)(6) 2018.On (b)(6) 2019, the patient was revised due to the patella was mal-tracking due to 2 degree to vmo weakness.Devices will not be returned, photos received.The patient was last known to be in stable condition following the event.All available information has been received.

Manufacturer Narrative

Section h10: (h3) the evaluation noted in the revision as reported, a 79 y/o female patient¿s right knee was initially implanted (b)(6) 2018.On (b)(6) 2019, the patient was revised due to the patella was mal-tracking due to 2 degree to vmo weakness.Devices will not be returned, photos received.The patient was last known to be in stable condition following the event.All available information has been received.Upon review of this event, there is no evidence this is a device related issue.The most likely cause was due to the 2 degree to vmo weakness, as reported; however, this cannot be confirmed due to the devices were not returned.(d11) concomitant device(s): lgc tibial fit tray cem sz 2.5f / 5t (cat# 02-012-45-2525 / sn# (b)(6).Lgc femoral ps cem right sz 2.5 (cat# 02-010-01-0325 / sn# (b)(6).Fluted stem extension 25l x 14 mm (cat# 204-34-02 / sn# (b)(6).Logic tibia implant psc insert, sz 2.5, 11mm (cat# 02-012-44-2511 / sn# (b)(6).No information provided in the following section(s): a4, a5, and b6.The following section(s) have additional info: b5, g4, g7, h1, h2, h3, h6 and h7.

• Brand Name: OPTETRAK
• Type of Device: THREE PEG PATELLA 32MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9368977
• MDR Text Key: 168183186
• Report Number: 1038671-2019-00583
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862039590
• UDI-Public: 10885862039590
• Combination Product (y/n): N
• PMA/PMN Number: K932690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2023
• Device Model Number: 200-02-32
• Device Catalogue Number: 200-02-32
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 05/08/2020
• Supplement Dates FDA Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR