MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT STD, SZ 4, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 02-010-03-0240 - logic cr femoral cem, left, sz 4 - 5236372; 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t - 5259172; 200-02-38 - three peg patella 38mm - 5257594.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that approximately 4 years 2 months post initial tka, the patient was revised due to pain and synovitis.The surgeon stated that the synovitis was mild and the insert was pitted.The patient was last known to be in stable condition.No further information available.
Additional Manufacturer Narrative
H6: the revision reported may have been the result of pain and synovitis as stated.An additional contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.However, this cannot be confirmed as the device was not returned for evaluation and radiographs were not provided.
Event or Problem Description
No device return anticipated, the hospital does not release devices to the reps.
Event or Problem Description
Additional information received via the legal department : it was reported via legal filing that on (b)(6) 2018 the patient had a left total knee arthroplasty.After the initial implant the patient ¿had been complaining of mechanical complications and chronic pain¿.On or about (b)(6) 2022 the patient underwent a revision surgery of his left knee due to implant loosing and significant synovitis.The surgeon noted that there was ¿moderate poly wear synovitis¿ and ¿small areas of obvious pitting and delamination of the polyethylene component¿.The postoperative diagnosis confirmed left total knee arthroplasty failed due to significant loosening, which is related to the failure in the polyethylene.The revision operative report was not supplied to this company for review.
Additional Manufacturer Narrative
These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
Additional information for investigation: according to the legal documentation, the patient was revised "due to implant loosening and significant synovitis.The postoperative diagnosis confirmed left total knee arthroplasty failed due to significant loosening, which is related to the failure in the polyethylene." according to exactech's surgery database and the information provided in the initial complaint submission, the surgeon elected to revise the patient's 11mm cr tibial insert to an 11mm crc tibial insert.The femoral component and tibial tray were not revised.Therefore, it does not appear that this revision was the result of loosening.The revision reported may have been the result of pain and synovitis as stated in the complaint submission.An additional contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.However, this cannot be confirmed as the device was not returned for evaluation and radiographs were not provided.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 4, 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15020986
• Report Number: 1038671-2022-00791
• Device Sequence Number: 20547157
• Product Code: JWH
• UDI-Device Identifier: 10885862174451
• UDI-Public: 10885862174451
• 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: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/10/2023

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: 03/22/2021
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 4, 11MM
• Device Catalogue Number: 02-012-47-4011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 01/16/2023; 04/03/2023; 05/01/2023
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 02/13/2023; 04/25/2023; 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown