MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-48-3011
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Joint effusion (4849)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: logic cr femoral cem, right, sz 3, (category #: 02-010-03-0330, serial #: (b)(4), lgc tibial fit tray cem sz 3f / 3t, (category #: 02-012-45-3030, serial #: (b)(4), knee item-misc, (category #: 200-00-00), three peg patella 35mm, (category #: 200-02-35, serial #: (b)(4), holding pin headless sharp point long 4pk, (category #: 201-78-14, serial #: (b)(4), holding pin mini sharp point 4 pk, (category #: 201-78-15, serial #: (b)(4), 11-4132 stryker sys 6 90x13/21x1.19, (category #: 203-96-42, serial #: (b)(4) correction/removal number: z-0021-2022.
Event or Problem Description
As reported, the female patient had an initial right tka on (b)(6) 2012.The patient was revised on (b)(6) 2022.
Additional Manufacturer Narrative
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 cannot be conclusively determined, insufficient information.This device is used for treatment, not diagnosis.F6 & f8 not required, as this is the manufacturer report.
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement surgery on (b)(6) 2012.They were subsequently revised on (b)(6) 2022, approximately 9 years 6 months after their primary procedure.(b)(6) 2022 op report findings: significant reactive tissue about both the femoral and tibial components, they were grossly loose, there was gross fracture of the polyethylene.The patellar button had minimal abrasive wear.There was a lot of osteolytic debris present throughout the knee.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
As a result of additional information received, the following fields have been updated: a2, a4, b5, b7, and g3.Further information and/or re-opened investigation findings will be provided within 30 days of receipt.
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the result of prosthesis wear, osteolysis, and insufficient bonds between the devices and the bones, which led to aseptic (non-infected) loosening.The extent and root cause of the prosthesis wear, osteolysis, and loosening could not be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d8, h6 - health effect - clinical code, medical device problem code, component code, type of investigation, investigation findings, h7 and h11 the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A definitive root cause was unable to be determined; however, may been the result of prosthesis wear, osteolysis, and insufficient bonds between the devices and the bones, which led to aseptic (non-infected) loosening.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h10.The following sections were corrected: e1, e2, e3 and h6 - health effect - clinical code.H10: multiple mdr reports were filed for this event, please see associated report: (b)(4).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 3, 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15877669
• Report Number: 1038671-2022-01516
• Device Sequence Number: 5361803
• Product Code: JWH
• UDI-Device Identifier: 10885862174390
• UDI-Public: 10885862174390
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/20/2026

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: 08/01/2019
• Device Model Number: 02-012-48-3011
• Device Catalogue Number: 02-012-48-3011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/08/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 11/17/2022; 06/12/2023; 09/25/2023; 04/20/2026; 04/20/2026
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 03/20/2023; 07/12/2023; 10/19/2023; 04/20/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2011
• 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; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 91 KG