MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-45-3020
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation medical concomitant device(s): 02-010-03-0330 - logic cr femoral cem, right, sz 3 sn: (b)(4), 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t sn: (b)(4), 200-02-29 - three peg patella 29mm sn: (b)(4).
Event or Problem Description
It was reported that this 69 y/o female patient's right knee had a poly swap.Straight forward swap- no incidents.Patient was last known to be in stable condition following the event.Device is not returning, hospital will not release.
Additional Manufacturer Narrative
Section h10: (h3) 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 was stated to be due to device recall; no other reason was reported.Section h11: *the following sections have corrected information: (b5) describe event or problem: it was reported that this 69 y/o female patient's right knee had a poly swap.Straight forward swap.There were no reported issues with the surgical procedure.Patient was last known to be in stable condition following the event.Device is not returning, hospital will not release.New information on 24 aug 22 - the representative stated that the poly swap was due to the device recall.No additional information.
Event or Problem Description
It was reported that this 69 y/o female patient's right knee had a poly swap.Straight forward swap.There were no reported issues with the surgical procedure.Patient was last known to be in stable condition following the event.Device is not returning, hospital will not release.New information on 24 aug 22 - the representative stated that the poly swap was due to the device recall.No additional information.
Additional Manufacturer Narrative
New information requires a new investigation.Pending investigation.These devices are used for treatment not diagnosis.No other information is available.
Event or Problem Description
Additional information-it was reported via legal documentation that the patient had a right total knee arthroplasty revision approximately 3 years, 6 months, after implant.The patient claims- pain, stiffness, discomfort, and weakness which in turn negatively affected mobility and quality of life and necessitated a revision surgery and the resultant pain following surgery and recuperation/rehabilitation period and physical therapy.There is no other information.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear 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.However, the reported prosthesis wear could not be confirmed and potential contributions of user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: LOGIC CR TIB INSERT SLOPE
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15372666
• Report Number: 1038671-2022-01046
• Device Sequence Number: 12343250
• Product Code: JWH
• UDI-Device Identifier: 10885862174383
• UDI-Public: 10885862174383
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 10/08/2024

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: 12/12/2020
• Device Model Number: 02-012-45-3020
• Device Catalogue Number: 02-012-48-3009
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 10/13/2022; 07/19/2023; 11/07/2024
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 11/08/2022; 10/06/2023; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female