MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 3,; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	234-03-03
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant: 02-012-45-3040 - lgc tibial fit tray cem sz 3f / 4t 2568237, 200-02-38 - three peg patella 38mm 3633171, 201-78-82 - collar fixation pin 2pk 40mm, quick release 4528430, 201-78-88 - 4" drill bit, mod.Hex 2-pk 4479446, 204-23-11 - ps tibial inserts sz 3, 11mm 1660598 (b)(4).
Event or Problem Description
As reported, the patient had an initial right tka on or about (b)(6) 2016 due to degenerative arthritis.After, the patient presented for an evaluation of his right knee as he had been complaining of mechanical complications and chronic pain.On or about (b)(6) 2022, the patient had revision surgery due to implant loosening osteolysis and significant synovitis.The surgeon noted that the femoral component was completely loose and removed by hand and that the patellar and tibial components were also loose and very easily extracted.The insert was noted to be cracked and fissured.
Additional Manufacturer Narrative
H3.Investigation results- the revision reported may have been the result of loosening, prosthesis wear, and osteolysis.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the femoral component, patella component, tibial tray and the bone.The tibial insert wear may have been due to malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the devices were not available for evaluation and images or radiographs were not provided.Additionally, the revised insert was packaged in a non-conforming vacuum bag for more than five years, which may have contributed to the reported wear.These devices are used for treatment not diagnosis.There is no other information available h11.Correction ¿ f6, should be blank.
Event or Problem Description
The patient was revised approximately 5 years, 10 months after implant.Explant date: (b)(6) 2022, it was reported that the patient ¿did well but over time [had] developed pain and increasing difficulty walking.¿ the preoperative evaluation was ¿suggestive of aseptic loosening and osteolysis/polyethylene failure consistent with the fact that there has been a recall from the manufacturer regarding the polyethylene.His work-up has been negative for infection.¿ on (b)(6) 2022, the patient was revised.Intraoperative findings included ¿[c]omplete wear of the total knee with a lot of reactive tissue in the joint.A gram stain was negative for infection¿the femoral component was completely loose and removed by hand.The patellar component and tibial component were also loose and very easily extracted.There was bone loss on the femur, the defects were contained.Similarly there was bone loss in the proximal tibia which was contained.¿ additionally, ¿the insert was noted to have cracking and fissuring.There was backside wear.The tibial spine was completely destroyed.¿ there were no noted complications.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: b3, h6.Mdr section codes updated/corrected: b, c, d, e, f, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening, prosthesis wear, and cracking.Or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.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 ASY,PS CEMENTED FEMORAL, SZ 3,
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainsville, FL 32653 ; 3523771140
• MDR Report Key: 15502020
• Report Number: 1038671-2022-01192
• Device Sequence Number: 7831810
• Product Code: JWH
• UDI-Device Identifier: 10885862063267
• UDI-Public: 10885862063267
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2025

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: 06/22/2021
• Device Model Number: 234-03-03
• Device Catalogue Number: 234-03-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/09/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 04/08/2024; 01/24/2025
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 05/02/2024; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2016
• 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: 62 YR
• Patient Sex: Male