MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 13MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	01/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product(s): three peg patella 38mm (cat# 200-02-38 / serial# 5661717).As reported, approximately 13 years postop the initial implant, the (b)(6) y/o male patient returned to hospital for instability and pain issues.It was noted there was some osteolysis in patella and femur.A revision was scheduled and performed.Upon exposure and debridement, it was noted that there was extreme bone loss in all compartment¿s femur, patella, and tibia.Even with the very extreme bone loss the attending surgeon decided the best option for this patient was to only replace the patella and insert.The insert was upsized by 2mm and a larger patella was cemented in.The attending also used grafton products in the bone voids.The device is not available for evaluation as the hospital retains all retrievals.Patient was last known to be in stable condition following the event instability is a known complication following total knee replacement surgery and is multifactorial in nature.Instability is listed as a potential adverse event associated with total joint replacement surgery in the product ifu (700-096-004).As noted in why are total knee arthroplasties failing today¿has anything changed after 10 years? (sharkey, p.L.(2014s, september).The journal of arthroplasty, 29), instability is in the top five reasons for that account for approximately 85% of total knee revisions (7.35% of revisions are for instability).Upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to instability of the joint over the course of 13 years.
Event or Problem Description
As reported, the patient returned to hospital for instability and pain issues.It was noted there was some osteolysis in patella and femur.A revision was scheduled and performed.Upon exposure and debridement, it was noted that there was extreme bone loss in all compartments femur, patella, and tibia.Even with the very extreme bone loss the attending surgeon decided the best option for this patient was to only replace the patella and insert.The insert was upsized by 2mm and a larger patella was cemented in.The attending also used grafton products in the bone voids.The device is not available for evaluation as the hospital retains all retrievals.

• Brand Name: OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11367620
• Report Number: 1038671-2021-00066
• Device Sequence Number: 19498264
• Product Code: JWH
• UDI-Device Identifier: 10885862064059
• UDI-Public: 10885862064059
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2022
• Device Model Number: OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 13MM
• Device Catalogue Number: 244-24-13
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/23/2021
• 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; Disability
• Patient Age: 66 YR
• Patient Weight: 79