MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-47-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: unknown which devices are left or right.(b)(6).02-010-03-0240 - logic cr femoral cem, left, sz 4.(b)(6).02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t.(b)(6).02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t.(b)(6).200-02-38 - three peg patella 38mm.(b)(6).200-02-41 - three peg patella 41mm.(b)(6).201-78-15 - holding pin mini sharp point 4 pk.(b)(6).201-78-81 - 3 trocar, mod.Hex 2pk.(b)(6).201-78-81 - 3 trocar, mod.Hex 2pk.(b)(6).201-78-81 - 3 trocar, mod.Hex 2pk (b)(6).521-78-23 - threaded pin size 2.3 collared.(b)(6).521-78-23 - threaded pin size 2.3 collared.(b)(6).521-78-36 - threaded pin size 5.1 collarless.(b)(6).A10012 - gps implant kit v2.(b)(6).A10012 - gps implant kit v2.H7: z-0021-2022.
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2021.The patient was revised on (b)(6) 2023 due to poly wear and the liner was exchanged.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: the reason for the revision cannot be confirmed from the information provided, but may be due to prosthesis wear as reported and/or inclusion of the polyethylene in the packaging recall with the involved tibial insert having been packaged in a non-conforming bag and on the shelf for over 5 years prior to implantation.However, this cannot be confirmed as the device was not available for evaluation.
Event or Problem Description
Operation report of 23 may 2023.Clear joint fluid was taken for microbiological analysis.A subtotal synovectomy was performed of the hypertrophied synovial tissue and specimens sent for histopathological analysis.The tibiofemoral polyethylene was removed and following extensive lavage of the joint a new 9 mm size 4 optetrak cr insert was applied.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 other information is available.
Additional Manufacturer Narrative
Investigation conclusions: h3.Investigation updated-the revision reported was likely the result of prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.Additionally, a contributing factor to the wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The extent and root cause of the prosthesis wear could not be determined as the device was not returned for evaluation, and radiographs were not provided.H11.Correction- f6, f8 should be blank.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 4, 9MM
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17159853
• Report Number: 1038671-2023-01400
• Device Sequence Number: 5386879
• Product Code: JWH
• UDI-Device Identifier: 10885862174444
• UDI-Public: 10885862174444
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2023

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: 08/01/2023
• Device Model Number: 02-012-47-4009
• Device Catalogue Number: 02-012-47-4009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/31/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 08/25/2023; 11/01/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 09/08/2023; 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male