MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4,

Model Number	234-02-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device: tibial insert (cn: 204-14-13, sn: (b)(4)).
Event or Problem Description
As previously reported, a male, (b)(6), received a tka in the past.The patient returned with an infection and it was decided that a two-stage revision should occur.The first stage of this case involved removing the old prosthesis and implanting a new tibia and femur as a spacer with antibiotics added to the cement.Patient was last known to be in stable condition following the event.Devices not returned due to facility policy.As reported the patient returned to the office 6 weeks after the antibiotic spacer was inserted and the second stage was planned.(current event, (b)(6) 2020) two days after the 6 weeks check, the patient had a fever, a wash out was done, and second spacer was implanted.Since the infection returned, it was decided to use the interspace antibiotic spacer.The surgeon wanted to use another femur/allpoly for this stage but decided to settle on the interspace antibiotic spacer.All went great and we are awaiting the second stage.The large interspace knee spacer was implanted perfectly.The knee was very stable and balanced awaiting the second stage of the revision.Device not returning.Patient was last known to be in stable condition following the event.Concomitant device: tibial insert (cn: 204-14-13, sn: (b)(4)).
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the revision reported uponon review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent placement of another antibiotic spacer cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Concomitant device: tibial insert (cn: 204-14-13, sn: (b)(6) no information provided in the following section(s): a4, a5, b6 the following section(s) have additional info: g4, g7, h1, h2, h3, and h7.

• Brand Name: OPTETRAK
• Common Device Name: OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10560332
• Report Number: 1038671-2020-00539
• Device Sequence Number: 16801210
• Product Code: JWH
• UDI-Device Identifier: 10885862063205
• UDI-Public: 10885862063205
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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: 10/24/2021
• Device Model Number: 234-02-04
• Device Catalogue Number: 234-02-04
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 12/22/2020
• 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: 74 YR