MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 244-25-11 - optetrak hi-flex tibial insert sz 5 11mm.(b)(6), 200-02-35 - three peg patella 35mm.(b)(6), 200-04-55 - cemented finned tib.Tra sz 5f/5t.(b)(6), 201-46-10 - holding pin headless 3" (4 pk).(b)(6), 203-90-01 - 11-2624 powerpro sawblade.(b)(6), 244-02-05 - optetrak asy hi-flex ps cem fem, sz 5, left.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6)2007.Approximately 15 years and 11 months after the initial procedure the patient had a left knee revision on (b)(6) 2023.The patient has suffered the following injuries: pain, suffering, and instability in his left knee.The components of his implant were noted to be grossly loose and were replaced.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.3044, and pending in the eastern district of new york.Per the transfer order creating this multidistrict litigation, ¿plaintiffs¿allege that their knee or hip replacement devices¿failed prematurely because of degradation of the device¿s polyethylene component, which resulted in the premature removal (or planned removal) of the prosthesis at issue.¿ because the patient has filed a suit in this multidistrict litigation, the patient appears to allege that the patient was injured as a result of premature wear of an exactech polyethylene device.
Additional Manufacturer Narrative
As a result of the investigation, the following fields have been updated: d1, d4, d10, g4, g4, h6, h7, and h9.D10.Concomitants: (b)(6), 200-02-35 - three peg patella 35mm.(b)(6), 200-04-55 - cemented finned tib.Tra sz 5f/5t.(b)(6), 201-46-10 - holding pin headless 3" (4 pk).(b)(6), 203-90-01 - 11-2624 powerpro sawblade.(b)(6), 244-02-05 - optetrak asy hi-flex ps cem fem, sz 5, left.H6.Investigation results - the revision reported may have been the result of polyethylene wear, instability and loosening as stated in the legal documentation.The aseptic (non-infected) loosening may have been the result of both patient-related conditions and insufficient bonds between the implants and the bones.The extent and root cause of the reported polyethylene wear cannot be determined as the explanted devices were not returned for evaluation, and radiographs, photographs, and operative notes were not provided.

• Brand Name: OPTETRAK HI-FLEX TIBIAL INSERT SZ 5 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17691058
• Report Number: 1038671-2023-02166
• Device Sequence Number: 6116548
• Product Code: JWH
• UDI-Device Identifier: 10885862064080
• UDI-Public: 10885862064080
• 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: 2007
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: 03/01/2011
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 244-25-11
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2006
• 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: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown