MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Subluxation (4525); Joint Laxity (4526)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by legal team, approximately ten years post initial bilateral tka, the male patient had a revision of his right knee for an unknown reason.No additional information available.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported by legal team, approximately ten years post initial bilateral tka, the male patient had a revision of his right knee for an unknown reason.No additional information available.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.
Event or Problem Description
As reported via legal documentation approximately 120 months after a right total knee replacement the patient underwent a revision surgery to address prosthetic wear and loosening.The patient has experienced a painful and unstable right knee replacement.Post operative report noted aseptic loosening of the femoral component and marked osteolysis.Upon exposing the knee, the surgeon observed extensive synovitis, the polyethylene liner was removed.There was noted to be wear of the liner.The femoral component was noted to be loose with significant fibrous tissue beneath it with significant amount of osteolysis of the distal femur.The patella was noted to be well fixed, but there was some wear on the patella.There was some osteolysis of the remaining patella that was debrided.Small femoral and tibial cysts were observed.No medical or surgical interventions were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6 - medical device problem code.The following sections were corrected: b5.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Additional information reported via legal documentation and patient reports states that approximately ten years post initial bilateral tka, the patient had a revision of his right knee for failed tka, aseptic femoral loosening, and osteolysis.Op notes further report, the patient presents with a painful and unstable right knee replacement.The patient was noted to have aseptic loosening of the femoral component and marked osteolysis.The patient has failed conservative management including activity modification and anti-inflammatory medications.All options were discussed in detail with the patient and he decided to proceed with revision right total knee replacement.The patella was subluxated laterally.There was very extensive synovitis, and a very thorough synovectomy of the joint was performed.The polyethylene liner was removed.There was noted to be wear of the liner.Next the femoral component was noted to be loose, and it was removed.There was significant fibrous tissue beneath it with massive osteolysis of the distal femur.There was no evidence of infection grossly although multiple specimens were sent to pathology.The patella was noted to be well fixed, but there was some wear on the patella.There was some osteolysis of the remaining patella that was debrided.The patient will be allowed to weight-bear as tolerated.Postoperative antibiotics as well as dvt prophylaxis will be administered.An x-ray will be obtained in the recovery room.The patient will be seen by the case manager/social worker who will coordinate the discharge plan.The patient will be discharged home from the hospital when comfortable and have met all physical therapy goals.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.No other information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and femoral loosening, or due to inclusion of the polyethylene in the packaging recall.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and product information 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: LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM
• 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15685964
• Report Number: 1038671-2022-01366
• Device Sequence Number: 12342510
• Product Code: JWH
• UDI-Device Identifier: 10885862173720
• UDI-Public: 10885862173720
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM
• Device Catalogue Number: 02-012-44-5011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 10/31/2022; 02/06/2023; 02/20/2024; 01/16/2025
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 11/21/2022; 01/15/2025; 01/15/2025; 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male