MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 02-012-45-1505 - lgc tibial fit tray cem sz 1.5f / 0.5t.(b)(6) 02-010-03-0315 - logic cr femoral cem, right, sz 1.5.(b)(6) 521-78-31 - threaded pin size 2.6 collarless 2pk.(b)(6) 02-012-48-1509 - logic cr tib insert slope +, sz 1.5, 9 mm.(b)(6) 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t.(b)(6) 02-010-03-0215 - logic cr femoral cem, left sz 1.5.(b)(6) 521-78-23 - threaded pin size 2.3 collared 2pk.(b)(6) 200-02-29 - three peg patella 29mm.(b)(6) 200-02-29 - three peg patella 29mm.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a bilateral knee replacement on (b)(6) 2016.Following the surgeries, the patient began experiencing severe pain, swelling, and unsteadiness in both knees, and significant gait impairment.Due to this worsening pain and instability caused by the accelerated wear of her implant, the patient underwent a left knee revision surgery on (b)(6) 2020.During her left knee revision surgery, the patient's surgeon noted ¿some wear of the tibial baseplate¿ and ¿significant wear of the tibial insert.¿ the patient's surgeon discovered ¿significant metallosis in the joint,¿ ¿deposition of metallosis in the soft tissue and in the bones of the knee joint,¿ and ¿significant destruction of soft tissue and bone from the metallosis which was present.¿ the patient's surgeon also noted increased ¿complexity of the case¿ due to the ¿significant metallosis in the joint¿ which ¿necessitate[ed] significant debridement of arthrofibrotic tissue with metallosis.¿ the surgeon discovered ¿significant bone loss, especially on the femoral side of the joint.¿ these issues resulted in an ¿extended time needed for surgical intervention with surgery,¿ with the revision surgery taking roughly four hours to complete.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
This follow-up report is being submitted to relay additional and/or corrected information.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-04669.D10: concomitants: (b)(6), 02-012-45-1505 - lgc tibial fit tray cem sz 1.5f / 0.5t, (b)(6), 02-010-03-0315 - logic cr femoral cem, right, sz 1.5, (b)(6), 521-78-31 - threaded pin size 2.6 collarless 2pk, (b)(6), 02-012-48-1509 - logic cr tib insert slope +, sz 1.5, 9 mm, (b)(6), 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t, (b)(6), 02-010-03-0215 - logic cr femoral cem, left sz 1.5, (b)(6), 521-78-23 - threaded pin size 2.3 collared 2pk, (b)(6), 200-02-29 - three peg patella 29mm, (b)(6), 200-02-29 - three peg patella 29mm.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, metal wear and/or due to inclusion of the polyethylene in the packaging recall.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, radiographs, and relevant clinical 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 CR TIB INSERT SLOPE +, SZ 1.5, 9 MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17424186
• Report Number: 1038671-2023-01814
• Device Sequence Number: 5955542
• Product Code: JWH
• UDI-Device Identifier: 10885862144379
• UDI-Public: 10885862144379
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 04/08/2024
• Device Model Number: LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM
• Device Catalogue Number: 02-012-48-1509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2016
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown