MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	OPTETRAK HI-FLEX TIBIAL INSERT SZ 5 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this (b)(6) male patient has a 6-month history of right knee pain.Patient had a revision of right knee components due to pain and instability.Prior to patient revision, on a pain scale, the knee was rated a 5/10 - 9/10 and is intermittent.The pain was particularly bad with standing and walking.The pain was located on the inside of and at the front of the knee.The pain was described as sharp.Patient complained of swelling and instability.As of most recently, the pain was getting worse.He underwent a right primary tka (b)(6) 2009.He initially had a very smooth recovery until about 5- or 6-years post-op when he developed a severe baker's cyst.He has had these drained multiple times including a surgical i&d, however it returns after being drained.As a result, he has had ongoing pain with weightbearing activities, pain and instability.This has significantly impacted his quality of life and has affected his ability to perform day to day activities.He notes that his symptoms have significantly worsened, as he has been barely able to walk for the past 1 month.
Additional Manufacturer Narrative
Concomitant medical products optetrak hi-flex tibial insert sz 5 9mm (cat# 244-25-09); optetrak asy hi-flex ps cem fem, sz 5, right (cat# 244-03-05); three peg patella 38mm (cat# 200-02-38).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Concomitant medical products optetrak hi-flex tibial insert sz 5 9mm (cat# 244-25-09); optetrak asy hi-flex ps cem fem, sz 5, right (cat# 244-03-05); three peg patella 38mm (cat# 200-02-38).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, this (b)(6) male patient has a 6-month history of right knee pain.Patient had a revision of right knee components due to pain and instability.Prior to patient revision, on a pain scale, the knee was rated a 5/10 - 9/10 and is intermittent.The pain was particularly bad with standing and walking.The pain was located on the inside of and at the front of the knee.The pain was described as sharp.Patient complained of swelling and instability.As of most recently, the pain was getting worse.He underwent a right primary tka (b)(6) 2009.He initially had a very smooth recovery until about 5- or 6-years post-op when he developed a severe baker's cyst.He has had these drained multiple times including a surgical i&d, however it returns after being drained.As a result, he has had ongoing pain with weightbearing activities, pain and instability.This has significantly impacted his quality of life and has affected his ability to perform day to day activities.He notes that his symptoms have significantly worsened, as he has been barely able to walk for the past 1 month.
Additional Manufacturer Narrative
H3: as reported, this 78 y/o male patient has a 6-month history of right knee pain.Patient had a revision of right knee components due to pain and instability.Prior to patient revision, on a pain scale, the knee was rated a 5/10 - 9/10 and is intermittent.The pain was particularly bad with standing and walking.The pain was located on the inside of and at the front of the knee.The pain was described as sharp.Patient complained of swelling and instability.As of most recently, the pain was getting worse.He underwent a right primary tka (b)(6) 2009.He initially had a very smooth recovery until about 5- or 6-years post-op when he developed a severe baker's cyst.He has had these drained multiple times including a surgical i&d, however it returns after being drained.As a result, he has had ongoing pain with weightbearing activities, pain, and instability.This has significantly impacted his quality of life and has affected his ability to perform day to day activities.He notes that his symptoms have significantly worsened, as he has been barely able to walk for the past 1 month.Based on 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 subsequent revision for pain and instability cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.

• Brand Name: OPTETRAK HI-FLEX TIBIAL INSERT SZ 5 9MM
• 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: 13455813
• Report Number: 1038671-2022-00179
• Device Sequence Number: 5786113
• Product Code: JWH
• UDI-Device Identifier: 10885862064073
• UDI-Public: 10885862064073
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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 Model Number: OPTETRAK HI-FLEX TIBIAL INSERT SZ 5 9MM
• Device Catalogue Number: 244-25-09
• 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: 01/16/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male