MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Joint Laxity (4526)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: concomitants: 1909312 200-02-32 - three peg patella 32mm 1907240 200-04-33 - cemented finned tib.Tra sz 3f/3t 99325 203-97-14 - zimmer series 11-3729-01 3 versipower pl 90x25x1 1903616 244-02-03 - optetrak asy hi-flex ps cem fem, sz 3, left 1916374 244-23-09 - optetrak hi-flex tibial insert sz 3 9mm.
Event or Problem Description
As reported via the legal department a 64 y/o female patient had a total left knee replacement on (b)(6) 2010.Approximately 12 years and 1 month later the patient had a left knee revision on (b)(6) 2023.(b)(6) 2023 v simms, rn- revision op report of (b)(6) 2023 op report states right knee-the sticker sheet of revision devices show 2 left devices and other information, including the discharge summary clearly indicate that the left knee was revised.Pre-procedure diagnosis: tka aseptic loosening, tka wear of articular bearing, and pain the medial lateral gutters were reestablished with debridement of synovitis and scar tissue.The polyethylene liner was removed without difficulty which was noted to have wear and discoloration.The femoral component was noted to be grossly loose and disimpacted off the distal femur without difficulty.The tibial component was noted to be grossly loose and disimpacted off the tibial plateau without difficulty.The patella was noted to have excellent tracking.Dressings were applied.The patient was awakened and transferred to recovery in stable condition.There were no complications.Discharged from hospital on (b)(6) 2023 to home to follow up with pcp and specialist.Patient condition upon discharge: fair.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Recall number: z-0019-2022.1038671-2024-05109, 1038671-2024-05108 this follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0019-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-05109, 1038671-2024-05108.D10: concomitants: (b)(6), 200-02-32 - three peg patella 32mm, (b)(6), 200-04-33 - cemented finned tib.Tra sz 3f/3t, (b)(6), 203-97-14 - zimmer series 11-3729-01 3 versipower pl 90x25x1, (b)(6), 244-02-03 - optetrak asy hi-flex ps cem fem, sz 3, left, (b)(6), 244-23-09 - optetrak hi-flex tibial insert sz 3 9mm.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, femoral loosening, and tibial loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16762842
• Report Number: 1038671-2023-00721
• Device Sequence Number: 3063672
• Product Code: JWH
• UDI-Device Identifier: 10885862063991
• UDI-Public: 10885862063991
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2018
• Device Model Number: OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM
• Device Catalogue Number: 244-23-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2010
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female